GB2620116A

GB2620116A - Antiseptic composition

Info

Publication number: GB2620116A
Application number: GB2209170.6A
Authority: GB
Inventors: Yaqub Najem
Original assignee: Wbpc Holding Ltd
Current assignee: Wbpc Holding Ltd
Priority date: 2022-06-22
Filing date: 2022-06-22
Publication date: 2024-01-03
Also published as: GB202209170D0

Abstract

(1) An antiseptic composition comprising (a) water; (b) an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more C1-C12 alkyl groups, and a C3-C12 di-ol; and (c) a preservative component comprising one or more isothiazolinone compounds of formula (1), wherein R1 is selected from H and C1-C12 alkyl; R2 and R3 are each independently selected from H, Cl and C1-C12 alkyl; or R2 and R3 are taken together to form a C6 aryl ring, is provided. The one or more isothiazolinone compounds of formula (1) preferably comprises one or more of methylisothiazolinone, methychlorolisothiazolinone, benzisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone and butylbenzisothiazolinone, particularly methylisothiazolinone and methychlorolisothiazolinone. The phenylalkanol is preferably phenylpropanol. The phenol substituted with one or more C1-C12 alkyl groups is o-cymen-5-ol. The C3-C12 di-ol is preferably decylene glycol. The composition preferably comprises at least 90 wt% water. The composition preferably further comprises 1.00 to 5.00 wt% of a viscosity increasing agent; 0.10 to 3.00 wt% of a skin conditioning agent; and/or 0.10 to 1.00 wt% of a neutralising agent. Preferably the composition comprises less than 10 wt% ethanol or isopropyl alcohol. The composition is preferably in the form of a hand sanitiser or rinse-off composition. The composition is preferably for use as prophylactic against infection, preferably by Pseudomonas aeruginosa and/or Escherichia coli. Preferably the composition is for use as a prophylactic against pneumonia, septic shock, urinary tract infection, gastrointestinal infection, skin and soft tissue infection, diarrhoea and meningitis.

Description

ANTISEPTIC COMPOSITION

The present invention relates to an antiseptic composition comprising an antibacterial component and an isothiazolinone preservative component, as well as uses of and methods of preparing the same. The present invention also relates to the use of the isothiazolinone preservative component for the for the synergistic improvement of the antibacterial activity of the antibacterial component.

BACKGROUND

Antiseptic compositions have been known since 1867 since the publication of "Antiseptic Principle of the Practice of Surgery' by Joseph Lister. Since then, various antiseptic compositions have been widely used for their antimicrobial properties. Antiseptic compositions are useful for maintaining cleanliness in various settings, for example in hospitals and bathrooms. Antiseptic compositions also play a role in the prophylaxis of communicable diseases caused by various microorganisms, this may be achieved for example by practicing hand washing using antiseptic compositions.

In recent times there has been an increased drive for the practice of good hygiene and cleanliness in view of the COVID-19 pandemic. Hand washing using antiseptic compositions is a simple but effective mitigation strategy for the impact of microorganism borne diseases.

Known antiseptic compositions often use alcohols, such as ethanol, or isopropyl alcohol (also known as rubbing alcohol) in high concentrations. Alcohol based antiseptics often comprise at least 50 to 70 % alcohol by volume and even up to 70 to 90 % alcohol. However, whilst alcohol based sanitising compositions are highly effective at killing microorganisms, there are negatives associated with using high levels of alcohol on the hands that lead to dry and brittle skin conditions.

Natural oils on the hands are stripped away throughout the day by the repeated exposure to high levels of alcohol in the sanitising compositions used for hand washing. In hospitals, as well as various other medical settings, and public places where hand sanitising compositions are used constantly throughout the day, this can accelerate the detrimental effect of skin damage on the hands.

Alcohol-free antiseptic compositions are also widely used which may contain antibacterial ingredients such as benzalkonium chloride. However, benzalkonium chloride is known to have ocular toxicity and irritant properties which make it poorly suited for application to the body, such as hand washing. Other alcohol-free antiseptics make use of antimicrobials such as triclosan or triclocarban. However, triclosan and triclocarban are known to be disruptive to the human endocrine system. Triclosan and triclocarban are also both toxic to aquatic organisms and to aquatic environments due to their high propensity to bioaccumulate. Many regulatory boards have thus begun to put restrictions on triclosan and triclocarban.

There remains an unmet need for the provision of a sanitising composition suitable for long term repeated use as an antiseptic and particularly a hand sanitiser.

SUMMARY

In one aspect, the present invention provides an antiseptic composition comprising: a) water; b) an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a C3 to C12 di-ol; and c) a preservative component comprising one or more isothiazolinone compounds of formula (1): 0 R3 formula (1) wherein R1 is independently selected from H and Ci to C12 alkyl; wherein R2 is independently selected from H, Cl and Ci to C12 alkyl; and wherein R3 is independently selected from H, Cl and Ci to Cl2 alkyl; or wherein R2 and R3 are taken together to form a C6 aryl ring.

In another aspect, the present invention provides a hand sanifiser comprising or consisting essentially of the composition as described herein.

In another aspect, the present invention provides a rinse-off product, comprising or consisting essentially of the composition as described herein.

In another aspect, the present invention provides a wipe comprising the composition as described herein In another aspect, the present invention provides a use of the composition described herein as a surface disinfectant.

In another aspect, the present invention provides a use of the composition described herein to kill and/or inhibit the growth of Pseudomonas aeruginosa and/or Escherichia coli on an inanimate object.

In another aspect, the present invention provides the composition for use as a prophylactic against one or more of pneumonia, septic shock, urinary tract infection, gastrointestinal infection, skin and soft tissue infection, diarrhoea, and meningitis.

In yet another aspect, the present invention provides use of a preservative component comprising one or more isothiazolinone compounds according to formula (1), for the synergistic improvement of the antibacterial activity of an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a 03 to 012 di-ol; R3 formula (1) wherein R1 is independently selected from H and Ci to 012 alkyl; wherein R2 is independently selected from H, Cl and Ci to 012 alkyl; and wherein R3 is independently selected from H, Cl and Ci to 012 alkyl; or wherein R2 and R3 are taken together to form a C6 aryl ring.

In a final aspect, the present invention provides method of preparing a composition as described herein, the method comprising combining water with the antibacterial 5 component and the preservative component.

DETAILED DESCRIPTION

The present inventors have surprisingly discovered an unexpected synergistic relationship between the antimicrobial component as described herein and the preservative component as described herein. The synergistic relationship allows for the composition to provide a greatly enhanced sanitising effect whilst including a reduced dosage of each active component to be used.

The antimicrobial component useful in the present invention comprises a phenylalkanol, a phenol substituted with one or more Ci to C6 alkyl groups, and a 03 to 012 di-ol.

A phenylalkanol is a phenyl ring substituted with an alkyl alcohol. For example, a phenylalkanol may consist of a phenyl ring substituted by a branched or straight chain Ci to 012 alkyl alcohol, preferably a branched or straight chain Ci to Cs alkyl alcohol, more preferably a branched or straight chain Ci to 06 alkyl alcohol. In a preferred embodiment, the phenylalkanol is phenylpropanol (also known as 3-phenyl-1-propanol).

A phenol substituted with one or more Ci to 012 alkyl groups is a phenol ring, independently substituted at one or more carbon atoms of the phenyl ring by a branched or straight chain Ci to 012 alkyl group. In a preferred embodiment the phenol is substituted with one or more branched or straight chain Ci to 06 alkyl groups, preferably one or more branched or straight chain Ci to 04 alkyl groups. The phenol substituted with one or more Ci to 012 alkyl groups, Ci to C6 alkyl groups, or Ci to 04 alkyl groups, may be substituted by from Ito 5 alkyl groups, preferably 1 to 3 alkyl groups, more preferably 2 alkyl groups.

In a preferred embodiment the phenol substituted with one or more Ci to 012 alkyl groups is o-cymen-5-ol (also known as 4-isopropyl-3-methylphenol).

A di-ol is a chemical compound containing two hydroxyl groups. An aliphatic diol is also called a glycol. A glycol having its hydroxy groups attached to adjacent carbon atoms is known as a vicinal glycol. In a preferred embodiment the 03 to 012 di-ol is a 03 to 012 glycol, preferably a C3 to 012 vicinal glycol. In a preferred embodiment the 03 to 012 di-ol is a Cio di-ol, preferably decylene glycol, more preferably vicinal decylene glycol (also known as decane-1,2-diol).

Thus, in preferred embodiments, the antimicrobial component comprises or consists essentially of phenylpropanol, o-cymen-5-ol and decylene glycol.

The antimicrobial component is readily biodegradable. For example, phenylpropanol and o-cymen-5-ol are both 83 % biodegraded by 28 days, whilst decylene glycol is 100 % biodegraded by 28 days. The importance of biodegradation is obvious in terms of environmental protection. This offers a significant advantage over any alternative antimicrobials which may be more persistent in the environment.

The preservative component useful in the present invention comprises one or more isothiazolinone compounds of formula (1): R3 formula (1) wherein R1 is independently selected from H and Ci to 012 alkyl; wherein R2 is independently selected from H, Cl and Ci to 012 alkyl; and wherein R3 is independently selected from H, Cl and Ci to 012 alkyl; or wherein R2 and R3 are taken together to form a 06 aryl ring.

In preferred embodiments, R1 is a Ci to 012 alkyl group, more preferably a Ci to Ci g alkyl group, even more preferably a CI to 04 alkyl group, most preferably methyl group.

In preferred embodiments, the one or more isothiazolinone compound of formula (1) comprises one or more of methylisothiazolinone, methychlorolisothiazolinone, 30 benzisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone and butylbenzisothiazolinone, preferably the one or more isothiazolinone compound of formula (1) comprises or consists essentially of methylisothiazolinone and methychlorolisothiazolinone.

In a preferred embodiment, the one or more isothiazolinone compound of formula (1) consists essentially of methylisothiazolinone and methychlorolisothiazolinone in a ratio of from 5:95 to 67:33 by weight, preferably 10:90 to 50:50 by weight, more preferably 20:80 to 40:60 by weight, for example 23:77 by weight.

The preservative component may also comprise a stabiliser, such as magnesium nitrate, magnesium chloride, copper sulphate, or any combination thereof, preferably magnesium nitrate. In some embodiments, the weight ratio of the one or more isothiazolinone compounds of formula (1) to the stabiliser is from 1:10 to 1:0.1, preferably from 1:5 to 1:1.

Compounds of the isothiazolinone class are known to act as preservatives and have been used to control bacteria, fungi, and algae in for example, cooling water systems, fuel storage tanks, pulp and paper mill water systems, oil extraction systems, wood preservation, and paints. Isothiazolinone compounds have also been used as antibiofouling agents in shampoos and the hulls of ships.

However, isothiazolinone preservatives display antimicrobial properties over a relatively long time period and are best suited to long term prevention of bacterial growth. Isothiazolinones are widely used in the cosmetics industry for their long-term antimicrobial protection, i.e. prevention of microbial growth over a period of several days to several months.

The combination of a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a C3 to 012 di-ol, for example, phenylpropanol, o-cymen-5-ol, and decylene glycol has antimicrobial properties and is itself suited for antimicrobial uses. Nevertheless, it has been surprisingly discovered that the inclusion of the preservative component as described herein synergistically improves the antimicrobial properties of said antimicrobial component. In particular, the synergistic improvement provided by the preservative component can be observed over a very short time which is well suited to personal hygiene applications, such as hand washing. The composition of the present invention comprising the antimicrobial component and the preservative component has been demonstrated to possess highly effective antiseptic properties at lower concentration than the antimicrobial component alone. Furthermore, the synergistically enhanced antiseptic properties have been shown to take effect within 60 seconds. The enhanced antibacterial activity exhibited by the antiseptic composition of the present invention takes place much more rapidly than would be expected based purely on the known long-term preservative activity of an isothiazolinone compound.

The antiseptic composition may be provided in any suitable form and may for example be in the form of a gel, a foam, a liquid, or a solid soap. The composition may therefore be in the form of a gel or another other non-liquid or viscous liquid. Thus, in some preferred embodiments, the sanitising composition of the present invention further comprises at least one viscosity increasing agent such as a gelling agent, preferably a cross-linked polymeric material such as a crosslinked acrylate polymer, for example a copolymer of an acrylic acid derivative, such as acrylic acid or methacrylic acid, or an ester thereof with a crosslinking agent such as a compound containing two or more acrylate groups, for example triacrylate or ethylene glycol dimethylacrylate.

In preferred embodiments, the antiseptic composition of the present invention further comprises at least one skin conditioning agent, preferably wherein the at least one skin conditioning agent comprises or consists essentially of glycerin.

In preferred embodiments, the antiseptic composition of the present invention further comprises at least one neutralising agent, for example a buffer to stabilise the pH of the composition, preferably the at least one neutralising agent comprises an alkanolamine such as aminomethyl propanol.

In preferred embodiments, the antiseptic composition of the present invention comprises less than 10 wt.% ethanol or isopropyl alcohol, preferably the composition is substantially free of ethanol or isopropyl alcohol.

Table 1 below outlines a typical composition of a gel composition according to the present invention.

Table 1. Typical Components of an antiseptic composition gel according to the present invention.

Component Function Inclusion Level (wt.%) Water Solvent 94.00 to 96.00 Acrylates Crosspolymer-4 (crosslinked acrylate polymer) Viscosity Increasing Agent 1.00 to 5.00 Glycerin Skin Conditioning Agent 0.10 to 3.00 Phenylpropanol, 0-cymen-5-ol, Decylene glycol Antimicrobial Component 0.10 to 0.50 Methylisothiazolinone and Methychlorolisothiazolinone Preservative Component 0.0005 to 0.0075 Aminomethyl Propanol Neutralising Agent 0.10 to 1.00 In preferred embodiments, the composition comprises: 0.1 10 1.0 wt.%, preferably 0.10 to 0.50 wt.% of the antibacterial component, for example 0.2 to 0.5 wt.%; and/or 0.00005 to 0.015 wt.%, preferably 0.0005 to 0.0075 wt.% of the preservative component, such as 0.001 to 0.005 wt.% of the preservative component, for example, about 0.0015 wt.% of the preservative component.

In preferred embodiments, the composition comprises at least 90 wt.% water, preferably from 90 to 98 wt.%, for example 94 wt.% to 96 wt.%.

In preferred embodiments, the composition further comprises: 1.00 to 5.00 wt.% of a viscosity increasing agent, preferably 2.00 to 4.00 wt.% of a viscosity increasing agent, preferably wherein the viscosity increasing agent is acrylates crosspolymer-4; 0.10 to 3.00 wt.% of a skin conditioning agent, preferably 0.20 to 1.00 wt.% of a skin conditioning agent, preferably wherein the skin conditioning agent is glycerin; and/or 0.10 to 1.00 wt.% of a neutralising agent, preferably 0.20 to 0.50 wt.% of a neutralising agent, preferably wherein the neutralising agent is aminomethyl propanol.

In preferred embodiments, the composition consists essentially of: water, the antibacterial component, the preservative component, a viscosity increasing agent; a skin conditioning agent and a neutralising agent.

In preferred embodiments, the composition comprises less than 0.5 wt.% of the antibacterial composition, for example less than 0.4 wt.% or less than 0.3 wt.% or less than 0.2 wt.%.

In preferred embodiments, the weight ratio of the one or more isothiazolinone compounds according to formula (1), to the combination of a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a C3 to 012 di-ol, is from 0.0375:1 to 0.001:1.

The antiseptic composition of the present invention has also been found to have excellent stability. A sample was stored for 1 year without any discolouration or sedimentation of the gel being observed.

In a preferred embodiment, the hand sanitiser is in the form of a gel, a foam, a liquid, or a solid soap, preferably a gel.

In a preferred embodiment, the composition as described herein, optionally in the form of a gel, a foam, a liquid, or a solid soap, is suitable also for rinse-off applications. Thus, the antiseptic composition as described herein may be in the form of a rinse-off composition.

The rinse-off composition may for example comprise a cleansing rinse-off product such as a soap, a shampoo, a hair-conditioner, foaming or gel face wash, foaming or gel hand wash, foaming or gel body wash or foaming or gel foot wash products and the like.

In the context of the present invention, a "rinse-off" application, or "rinse-off' product refers to a product which is intended to be removed after application on the skin, the hair, or the mucous membranes. Alternatively, a "leave-on" application, or "leave-on" product means a product which is intended to stay in prolonged contact with the skin, the hair, or the mucous membranes.

As the present composition can produce a sanitising effect within a short time span, for example, within 60 seconds, the antiseptic composition of the present invention is well suited to leave-on applications and for use in rinse-off products, in the context of which the contact time is restricted.

Furthermore, the composition described herein may also be used in cleansing wipe substrates for face, hands, body, and feet.

The composition described herein may be impregnated into various mesh wipe substrates to provide protection against harmful bacteria and provide gentle cleansing and conditioning benefits on the skin. In another aspect, the present invention provides a wipe comprising the composition as described herein. The wipe may suitably comprise a wipe substrate impregnated with the composition described herein. The wipe substrate may comprise any suitable substrate such as a woven or non-woven fabric, which many be made from natural or synthetic fibres. For example, the wipe substrate may comprise synthetic fibres such as polyester or polypropylene or many comprise cellulose-based fibres such as cotton or bamboo.

In another aspect, the present invention provides a use of the composition described herein as a surface disinfectant.

In another aspect, the present invention provides a use of the composition described herein to kill and/or inhibit the growth of Pseudomonas aeruginosa and/or Escherichia coil on an inanimate object. Pseudomonas aeruginosa and Escherichia coil are both pathogenic bacteria in humans and are responsible for disease.

Surface disinfection, as well as killing and/or inhibiting growth of pathogenic bacteria is useful in cleaning, for example, in the cleaning of hospital or other medical equipment, potential fomites, living space, bathrooms, etc. In another aspect, the present invention provides the composition for use as a prophylactic against one or more of pneumonia, septic shock, urinary tract infection, gastrointestinal infection, skin and soft tissue infection, diarrhoea, and meningitis. These diseases or disease states are all potentially caused by one or both of Pseudomonas aeruginosa and/or Escherichia coli infection. Thus, the present antiseptic composition having antimicrobial activity against Pseudomonas aeruginosa and/or Escherichia coli is an effective prophylaxis against septic shock, urinary tract infection, gastrointestinal infection, skin and soft tissue infection, diarrhoea, and meningitis.

In another aspect, the present invention provides use of a preservative component comprising one or more isothiazolinone compounds according to formula (1), for the synergistic improvement of the antibacterial activity of an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more 01 to 012 alkyl groups, and a C3 to 012 di-ol; R3 formula (1) wherein R1 is independently selected from H and Ci to C12 alkyl; wherein R2 is independently selected from H, Cl and Ci to 012 alkyl; and wherein R3 is independently selected from H, Cl and Ci to 012 alkyl; or wherein R2 and R3 are taken together to form a 06 aryl ring.

zo In preferred embodiments, the R1 is a Ci to 012 alkyl group.

In preferred embodiments, the one or more isothiazolinone compounds of formula (1) comprises one or more of methylisothiazolinone, methychlorolisothiazolinone, benzisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone and butylbenzisothiazolinone, preferably wherein the one or more isothiazolinone compound of formula (1) comprises or consists essentially of methylisothiazolinone and methychlorolisothiazolinone.

In preferred embodiments, the synergistic improvement of the antibacterial activity of an antibacterial component comprises an increase in antibacterial activity over 10 minutes, preferably over 5 minutes, more preferably over 3 minutes, even more preferably over 1 minute, most preferably over 30 seconds.

Any modification, feature, or variation described above with regard to the antimicrobial and preservative components, for example, species, weight %, ratio, etc may also be applied to the above described use of a preservative component comprising one or more isothiazolinone compounds according to formula (1), for the synergistic improvement of the antibacterial activity of an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a 03 to 012 di-ol.

In another aspect, the present invention provides method of preparing a composition as described herein, the method comprising combining water with the antibacterial component and the preservative component.

The composition as described herein may be prepared by combining water with the antibacterial component and the preservative component. The antimicrobial component and the preservative component may be each combined with water separately and then combined together or may be each added to water either together or sequentially in any order. Preferably, the water, antimicrobial component and preservative component are mixed during or after any additions. Mixing may be easily achieved by known methods such as mixing by hand, or mechanical mixing, depending on the scale.

Phenylalkanols, phenols substituted with one or more Ci to 012 alkyl groups, and a 03 to 012 di-ols, including phenylpropanol, o-cymen-5-ol and decylene glycol are commercially available as well as being preparable synthetically by various routes within the capabilities of the skilled person. Various isothiazolinone compounds according to formula (1), including methylisothiazolinone and methychlorolisothiazolinone are also commercially available. Nevertheless, isothiazolinone compounds according to formula (1) may also be prepared by various synthetic routes within the capabilities of the skilled person.

The invention will now be described by reference to the following non-limiting Examples.

EXAMPLE 1

The antimicrobial properties of an antiseptic gel composition according to the present invention were tested using EN 1276:2019, which is a standard test for the evaluation of bactericidal activity of chemical sanitising agents.

Antiseptic gel composition of Example 1 * 0.5 wt.% of a combination of phenylpropanol, o-cymen-5-ol and decylene glycol; * 0.0015 wt.% methylisothiazolinone and methychlorolisothiazolinone in an approximately 1:3 weight ratio; * 94 to 96 wt.% water; * 2 to 4 wt.% crosslinked acrylate polymer as a viscosity increasing agent; * 0.2 to 1.0 wt.% glycerin as a skin conditioning agent; and * 0.2 to 0.5 wt.% aminomethyl propanol as a neutralising agent.

Experimental conditions Product diluent used: Sterile distilled water zo Product test concentrations: 80.0% v/v; 50.0% v/v; 10.0% v/v as compared to the Appearance product dilutions: antiseptic composition described above Appearance in test mixture: Contact time: No changes noted Test temperature: No changes noted Interfering substance: t = 60 seconds Temperature of incubation: 20°C ± 1°C 0.3g/I bovine albumin 37°C ± 1°C Bacteria Strains Tested Pseudomonas aeruginosa ATCC 15442 Escherichia coil ATCC 10536 Table 2. EN 1276:2019 Test Results for a Composition of the Present Invention.

Test Organism Test procedure at concentration To (v/v) 10.00 % 50.00 % 80.00 % Pseudomonas aeruginosa ATCC 15442 Vc > 330; > 330 0;0 0;U Na >3.30E+03 1.40E+02 1.40E+02 R <10(5) >10(5) >10(5) Escherichia coli ATCC 10536 Vc > 330;> 330 0; 1 0, 0 Na >3.30E+03 1.40E+02 1.40E+02 R <10(5) >10(5) >10(5) VC = viable count (the upper limit for detection is 330 colony forming units) Na = number of colony forming units in test mixture after contact time R = reduction in viability (Logi0) The antibacterial component itself, that is a mixture of phenylpropanol, o-cymen-5-ol and decylene glycol without methylisothiazolinone and methychlorolisothiazolinone, has been found to provide a 5 log reduction in viability at a concentration of 0.5 wt.%, whilst the antiseptic composition of Example 1 comprising methylisothiazolinone and methychlorolisothiazolinone is shown to provide a 5 log reduction in viability at only half this concentration of the antibacterial component (test procedure at 50 % concentration in Table 2). As will be appreciated, a 5 log reduction in viability corresponds to deactivating 99.999% of the bacteria.

Thus, the test results outlined in Table 2 show that the addition of the preservative component as described herein provides a synergistic improvement of the antibacterial activity of the antibacterial component as described herein. The composition of Example 1 has the same antimicrobial activity at a concentration of at least half of that of the antibacterial component alone (where the preservative component is not present). Additionally, the tests of Example 1 were conducted over a 60 second timespan which demonstrates that the preservative component provides an increase in activity to the antimicrobial component that is effective within a very short time span as compared to the usual activity of the preservative component alone. The composition of Example 1 was also found to have excellent stability when stored for 1 year without any discolouration or sedimentation of the gel being observed, demonstrating that the components are compatible and stable in combination.

Table 3 below outlines the validation tests for the EN 1276:2019 test results outlined in Table 2. As can be seen from Table 3, the tests outlined in Table 2 were all positively validated.

In Table 4, the following terms are used: Vc = variable count Nv = number of colony forming units / ml in the bacterial validation suspension N = number of colony forming units / ml in the bacterial test suspension Q = quotient of control of weighted mean counts A = number of colony forming units I ml in the experimental conditions validation B = number of colony forming units / ml in the neutraliser toxicity validation C = number of colony forming units / ml in the dilution-neutralisation validation Table 3. EN 1276:2019 Validation Test Results for a Composition of the Present Invention.

Test Organism Pseudomonas aeruginosa Escherichia coli ATCC ATCC 15442 10536 Bacterial Suspension (Nv) Vc: 57; 67 VC: 86; 95 Nv: 6.20E+02 Nv: 9.05E+02 Validation 30 s Nvo s 160? 30 s Nvo s 160? Yes Yes Experimental Conditions (A) Vc: 66; 49 Vc: 109; 92 A: 5.75E+01 A: 1.01E+02 Validation A L 0.5 x Nvo ? A L 0.5 x Nvo ? Yes Yes Neutraliser Toxicity (B) Vc: 39; 67 Vc: 88; 104 B: 5.30E+01 B: 9.60E+01 Validation B 0.5 x Nvo ? B 0.5 x Nvo ? Yes Yes Dilution-Neutralisation Control (C) Vc: 46; 40 Vc 94; 97 C: 4.30E+01 C:9.55E+01 Validation 0.5 x Nvo ? 0.5 x Nvo ? Yes Yes Bacterial Test Suspension (N) 10-6. 211; 241 10-6: >330; >330 10-7: 41; 26 10-7: 40; 42 N: 2.36E+08 N: 4.10E+08 Q: 6.75 Q: n/a Validation 7.17 s Log No s 7.70? 7.17 s Log No s 7.70? Yes Yes

Claims

Claims 1. An antiseptic composition comprising: a) water; b) an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more Ci to 012 alkyl groups, and a C3 to 012 di-ol; and c) a preservative component comprising one or more isothiazolinone compounds of formula (1): 0 R3 formula (1) wherein R1 is independently selected from H and Ci to C12 alkyl; wherein R2 is independently selected from H, Cl and Ci to 012 alkyl; and wherein R3 is independently selected from H, Cl and Ci to 012 alkyl; or wherein R2 and R3 are taken together to form a 06 aryl ring.
2. The composition of Claim 1, wherein R1 is a Ci to 012 alkyl group.
3. The composition of Claim 1, wherein the one or more isothiazolinone compound of formula (1) comprises one or more of methylisothiazolinone, methychlorolisothiazolinone, benzisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone and butylbenzisothiazolinone, preferably wherein the one or more isothiazolinone compound of formula (1) comprises or consists essentially of methylisothiazolinone and methychlorolisothiazolinone.
4 The composition of any one of the preceding claims, wherein the phenylalkanol is phenylpropanol.
5. The composition of any one of the preceding claims, wherein the phenol substituted with one or more Ci to 012 alkyl groups is o-cymen-5-ol.
6. The composition any one of the preceding claims, wherein the 03 to 012 di-ol is decylene glycol.
7. The composition of any one of the preceding claims, further comprising one or more of: at least one viscosity increasing agent, preferably a cross-linked polymeric material such as a crosslinked acrylate polymer, for example a copolymer of an acrylic acid derivative or an ester thereof with a crosslinking agent such as a triacrylate: at least one skin conditioning agent, preferably wherein the at least one skin conditioning agent comprises or consists essentially of glycerin; and/or at least one neutralising agent, preferably wherein the at least one neutralising agent comprises an alkanolamine such as aminomethyl propanol.
8. The composition of any one of the preceding claims, wherein the composition comprises less than 10 wt.% ethanol or isopropyl alcohol, preferably wherein the composition is substantially free of ethanol or isopropyl alcohol.
9. The composition of any one of the preceding claims, comprising: 0.1 to 1.0 wt.%, preferably 0.20 to 0.50 wt.% of the antibacterial component; and 0.00075 to 0.015 wt.%, preferably 0.0005 to 0.0075 wt.% of the preservative component.
10. The composition of any one of the preceding claims, comprising at least 90 wt.% water, preferably from 90 to 98 wt.%, for example 94 wt.% to 96 wt.%.
11. The composition of any one of the preceding claims, further comprising: 1.00 to 5.00 wt.% of a viscosity increasing agent; 0.10 to 3.00 wt.% of a skin conditioning agent; and/or 0.10 to 1.00 wt.% of a neutralising agent.
12. The composition of any one of the preceding claims, consisting essentially of: water, the antibacterial component, the preservative component, a viscosity increasing agent; a skin conditioning agent and a neutralising agent.
13. The composition of any preceding claim, wherein the composition comprises less than 0.5 wt.% of the antibacterial composition, for example less than 0.4 wt.% or less than 0.3 wt.% or less than 0.2%wt.
14. A hand sanitiser or a rinse-off product, comprising or consisting essentially of the composition of any preceding claim, preferably a hand sanitiser in the form of a gel, a foam, a liquid, or a solid soap, preferably a gel; or a wipe comprising the composition of any preceding claim.
15. The use of a composition according to any one of Claims 1 to 13 as a surface disinfectant.
16. The use of a composition according to any one of Claims Ito 13 to kill and/or inhibit the growth of Pseudomonas aeruginosa and/or Escherichia coli on an inanimate object.
17. The composition of any one of Claims 1 to 13 for use as a prophylactic against infection, preferably against infection by Pseudomonas aeruginosa and/or Escherichia coll.
18. The composition of any one of Claims 1 to 13 for use as a prophylactic against one or more of pneumonia, septic shock, urinary tract infection, gastrointestinal infection, skin and soft tissue infection, diarrhoea, and meningitis.
19. The use of a preservative component comprising one or more isothiazolinone compounds according to formula (1), for the synergistic improvement of the antibacterial activity of an antibacterial component comprising a phenylalkanol, a phenol substituted with one or more C1 to 012 alkyl groups, and a C3 to 012 di-ol; R3 formula (1) wherein R1 is independently selected from H and Ci to 012 alkyl; wherein R2 is independently selected from H, Cl and Ci to 012 alkyl and wherein R3 is independently selected from H, Cl and Ci to C12 alkyl; or wherein R2 and R3 are taken together to form a 06 aryl ring.
20. The use of Claim 19, wherein R1 is a Ci to 012 alkyl group; or wherein the one or more isothiazolinone compounds of formula (1) comprises one or more of methylisothiazolinone, methychlorolisothiazolinone, benzisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone and butylbenzisothiazolinone, preferably wherein the one or more isothiazolinone compound of formula (1) comprises or consists essentially of methylisothiazolinone and methychlorolisothiazolinone.
21. The use of Claim 19 or Claim 20, wherein the C3 to 012 di-ol is decylene glycol.
22. The use of any one of Claim 19 to Claim 21, wherein the phenylalkanol is phenylpropanol.
23 The use of any one of Claim 19 to Claim 22, wherein the phenol substituted with one or more Ci to 012 alkyl groups is o-cymen-5-ol.
24. The use of any one of Claim 19 to 23, wherein the weight ratio of the one or more isothiazolinone compounds according to formula (1), to the combination of a phenylalkanol, a phenol substituted with one or more C1 to 012 alkyl groups, and a C3 to 012 di-ol, is from 0.0375:1 to 0.001:1.
25. A method of preparing a composition according to any one of Claims 1 to 13, the method comprising combining water with the antibacterial component and the preservative component.