The present invention relates to a liquid aqueous composition for the prevention, reduction and/or treatment of burns caused by contacting of the skin of a body part of a human or animal with one or more chemicals which are capable of causing burns, according to the preamble of the first claim.

A wide variety of compositions are available on the market to provide first aid for burns caused by contact of the skin or eyes or other body parts of humans or animals with etching chemicals, such as acids and alkaline chemicals, as well as burns caused by contact with other etching chemicals such as herbicides, pesticides, detergents and other. Chemical burns are produced by the action of chemicals on the skin and underlying tissues. The reaction of the chemicals with the skin is similar to the reaction of the skin in case of wounds caused by thermal burning. However, treatment agents commonly used for the treatment of thermal burns are not always suitable for use in the case of chemical burns. The chemical substance often remains present on the skin for a longer period of time after the first contact has occurred, it may be present in a possible wound and may remain present there for a longer period of time, unless being washed off. There is further a risk that the chemical substance penetrates deeper into the skin and/or the body. Besides damaging of the skin or body part that has been contacted by the chemical substance, with chemical burns there is an additional risk to intake of the chemical substance through the skin and a risk of aspiration of the chemical into the bloodstream.

The treatment commonly given after a contact of the skin or the body with chemicals aims in the first instance to minimize the effect of the chemical substance. A commonly used treatment encompasses a thorough rinsing with excessive water in order to dilute and rinse away the chemical as much as possible and minimize its impact. However, with chemical burns which are for example caused by strong bases or acids, this offers no solution because dilution of the chemical may take a long time and the chemical burn will continue as well as the possible penetration of the chemical into the body.

A well-known treatment agent for the treatment of chemical burns is Diphoterine, which is available as an eye wash bottle, as a spray for skin rinsing and as a complete shower for treating and rinsing of large areas or of the entire body. This is for example described in the International Journal of Dermatology, 2010, 49, 894-900 by Michael A. Donoghue et al. Diphoterine is an amphoteric chelating hypertonic aqueous solution, which is mainly used for ophthalmological applications, but also for the treatment of chemical burns on the skin caused by bases. Diphoterine contains a chelate which is intended to react with the chemical acids or alkaline compounds which cause burns.

In Rihawi S. et al., Graefe's Arch Clin. Exp. Ophthalmol. (2006)

244: 845-854 the effect is compared of Previn, Diphoterine, Cederroth Eye Wash Solution and water, in the treatment of artificial eyes burned caused by an alkaline solution. Treatment of an eye burned with alkali using a Cederroth Eye Wash Solution (neutral pH), which is a physiological solution of 0.9% NaCl solution and sodium tetraborate, provides a pH of 9.1 after rinsing for more than 800 seconds, this is more than 13 minutes. This is a very long period of time and may lead to serious damage to the eye especially in view of the pH at the end point of the treatment which is still 9.1. This pH is still considerably higher than the normal pH of the eye, which usually is in the vicinity of a neutral pH of about 7. Rihawi S. et al., therefore does not teach that treatment of an alkaline burn with a physiological solution makes it possible to neutralise the alkaline burn to a pH to approximately 7. This publication does not teach anything on the use of a sodium tetraborate/boric acid buffer and does not teach anything on the treatment of chemical burns caused by acid chemicals. Rihawi S. et al. discloses in Burns 34 (2008) 1027- 1032 that the treatment of an eye that has come into contact with an alkaline medium causes the pH of the eye to rise from over 12, and then after about 20 minutes of treatment to decrease to a value above 9. However, this is a pH which is substantially higher than that of the eye or of the skin. This publication does not teach that the desired end point of a neutral pH of the skin or the eye can be achieved by a treatment with a Cederroth formulation. The treatment solutions described in the above-mentioned publication all show the drawback that the pH not only decreases only very slowly upon the treatment, but also that it remains substantially higher than the near-neutral pH of the skin or the eye. As a result hereof burns may continue to develop.

This is confirmed by Wang Hui-fei, et al, in the Journal of Chinese People's Armed Police Forces Academy, June 2009, vol. 25, 6, (XP55205689), which describes that at a faster decontamination, better rehabilitation may be achieved. The effect of Diphoterine is compared to that of boric acid. This publication describes the use of a boric acid solution having a pH of about 4 for the treatment of alkaline burns, it does not disclose the use of an aqueous solution containing a boric acid/sodium tetraborate buffer.

BE 1005567 describes an autonomous portable shower for washing with Diphoterine, body parts which have been in contact with chemicals. The shower includes a portable container, which contains a compressible volume filled with Diphoterine and a propellant cartridge. The container is further provided with a lance and a diffuser for the application of the washing liquid to the contaminated site. Upon piercing of the cartridge, the propellant is released and the washing liquid is forced to flow to the outside.

The use of an aqueous solution of boric acid as a disinfectant in eye lotions as a very dilute solution (typically 1.5 percent boric acid dissolved in sterilized water) is known per se as well. Also the use of boric acid- containing alcohol solutions such as eardrops is known. From WO2010 / 078883 a disinfectant is known which contains a vitamin, at least one metal ion, a surfactant and an antimicrobial agent, for example boric acid. This disinfectant not only exhibits a good compatibility with a wide range of hard surfaces such as plastic surfaces, but is also suitable for use on the skin and mucous membranes. The disinfectant has also shown to be able of effectuating a degradation of nucleic acids and that way to provide an efficient disinfection.

There is thus still a need for a solution with which chemical burns caused by contact of the skin or eyes of humans or animals with chemicals, may be prevented and/or treated.

The object of this invention therefore is to provide a composition for the treatment of skin and/or eyes, wherein the skin and/or eyes can be both human and animal, which potentially or effectively have come into contact with one or more chemicals, wherein the composition is capable of minimizing the risk to the occurrence of burns that may occur as a result of their contact with the one or more chemicals.

This is achieved according to this invention with a composition showing the technical features of the characterizing portion of the first claim.

To this end, the present invention relates to a liquid aqueous composition the prevention, reduction and/or treatment of burns caused by contact of the skin of a body part of a human or animal with one or more chemicals, wherein the composition contains water, and a buffer of boric acid and a tetraborate salt, wherein the composition has a pH between 6.5 and 9.0.

The contact with the one or more chemicals may have occurred on the skin, but it may also have occurred to the eyes or other body parts. The contact with the one or more chemicals may have occurred through contact via a different surface, for example, clothing, a hard surface or the like. Preferably, the liquid aqueous composition of this invention contains a buffer of boric acid/sodium tetraborate. A boric acid / sodium tetraborate buffer generally has a pH of between 7.4 and 9.2, and shows a fast buffering action to both alkaline and acidic solutions, as is illustrated in the examples below.

The liquid, aqueous composition of this invention is typically an aqueous solution which is conventionally employed by applying a quantity of the solution to the part of the body, the skin or clothing that possibly or effectively came into contact with the chemicals, or by rinsing it therewith. Rinsing, regular refreshing and especially prolonged rinsing with the aqueous composition of this invention, has the effect that the composition is continuously refreshed so that always a sufficient quantity of buffer is present for reaction with or neutralization of the chemicals present, in particular acid or alkali, and the concentration of the chemicals may be diluted progressively. The inventors believe that the buffer present in the composition reacts with the burn-causing chemicals and that way

effectuates its neutralization.

The inventors have found that application of the composition of this invention at a point of time as soon as possible after a contact has occurred with the chemicals capable of causing the burns, is capable of ensuring a far-reaching neutralization of the chemicals. Not only is it in this way possible to preventively reduce the risk to the formation of burns and to even prevent the occurrence of burns, also the degree of a possible burning of the skin may considerably be reduced. The inventors have in particular found that the severity of any burns occurred can be seriously reduced by ensuring a contact with the composition of this invention, as soon as possible after contact with the chemical has occurred. The inventors have further found that the use of the composition of this invention is associated with a minimal risk to the occurrence of undesired adverse side reactions, on the human body or with animals. The inventors have even found that the occurrence of burns may be completely prevented by a preventive use of the composition of this invention. The composition of this invention can therefore be used

preventively in order to prevent the occurrence of burns, by applying to the part of the skin or clothing where there is a risk of undesired contact with chemicals, or by contacting or rinsing the skin or clothing for a prolonged period of time with the composition of this invention. This is especially useful for people who have been wearing special protective clothing with the purpose of minimizing the risk to contact with chemicals. By rinsing the clothing prior to undressing, any chemicals present on the clothing may be neutralized and the risk to chemical burns due to contact with chemicals present on the clothing may be minimized as well. In another possible preventive application the body or body part that possibly came into contact with the chemical, is rinsed. A treatment, for example rinsing with the composition of this invention can be provided as a standard procedure when finalizing handling of aggressive chemicals, regardless of the fact whether skin contact occurred or not.

The composition of this invention further offers the advantage that hardly any or no reaction heat is produced when it comes into contact with chemicals, so that the risk to an additional thermal burn may be prevented.

The amount of water and buffer and other additives present in the composition of this invention can be varied within wide limits.

Preferably, the composition of this invention contains between 80.0 and 98.0 wt. % of water, more preferably between 85.0 and 98.0 wt. % or between 90.0 and 99.0 wt. %, most preferably between 90.0 and 98.0 wt. %, in particular between 95.0 and 98.0 wt. %.

The composition of this invention preferably contains between 0.025 and 20.0 wt. % of a boric acid/tetraborate buffer, more preferably between 0.025 and 15.0 wt. %, in particular between 0.025 and 10.0 wt. % of a boric acid/sodium tetraborate buffer, more preferably 0.1-10.0 wt. %, most preferably 0.1-5.0 wt. %, in particular between 0.5 and 3.0 wt. %, more in particular between 0.5 and 1.5 wt. %. A boric acid/sodium tetraborate buffer generally has a pH between 7.4 and 9.2 as is described in

ww.ou.edu/research/electo^ The pH of the composition of this invention is controlled by adjusting the amount of buffer.

The composition of this invention will usually take the form of a liquid, in particular an aqueous solution, the viscosity of which can be adjusted in order to achieve the desired fluidity by adding a thickening agent.

This invention also relates to a composition having an increased viscosity, in particular a viscosity of at least 2 mPa.s, more particularly at least 5 mPa.s or 10 mPa.s, preferably at least 20 mPa.s, more preferably at least 50 mPa.s, more preferably at least 250 mPa.s, most preferably at least 500 mPa.s, in particular at least 1000 mPa.s, measured at 20 ° C. The viscosity will usually not be higher than 10 ⁵ , preferably not higher than 10 ⁴ mPa.s. To this end, the composition of this invention contains preferably between 0.05 and 10.0 wt. % of one or more thickening agents, more preferably between 0.05 and 5 wt. %, most preferably between 0.5 and 2.5 wt. %, although the amount of thickening agent may be varied within wide limits taking account the envisaged viscosity and the nature of the

thickening agent used.

The viscosity of at least 2 mPa.s, preferably at least 5 mPa.s assures that the composition of this invention is sufficiently fluid,

so that is capable of being spread over the contaminated skin surface, and at the same time that the composition is sufficiently viscous so that a good covering with a sufficiently thick layer of the contaminated skin surface may be obtained, to allows for a reaction with the chemicals present on the skin so that neutralization of the pH of the skin or eyes may be realized within the shortest possible time, also because of the action of the buffer present in the composition. The increased viscosity ensures that a prolonged contact time between the composition of this invention and the

contaminated skin or eyes is made possible, so that optimum neutralization of the chemicals present on the skin can be ensured by the buffer present in the composition of this invention. A composition with a slightly higher viscosity may as a rule be applied in a slightly greater layer thickness so that refreshing may take place within the layer thickness and a sufficient amount of buffer is present and remains present to permit for a

neutralization of the chemicals present. This permits to reduce the risk to further skin contact with the chemicals to a minimum. Liquids having a low viscosity such as water will after having been applied to a surface, show a tendency to flow away rather quickly, especially if the surface is not horizontal and uneven. The use of a composition having an increased viscosity not only provides a dilution effect, but also ensures a cooling effect and provides the possibility to extend the contact time of the composition of this invention with the skin as well as with the unwanted chemicals present on the skin. This offers the advantage that the risk of penetration of chemicals deep into the skin and the formation of possible deep burns associated therewith can be significantly reduced and may even be avoided. Such a composition with an increased viscosity is furthermore also able to penetrate the material of clothing and to there continue the neutralizing effect, of course, depending on the nature and porosity of the material from which the clothing is manufactured.

Within the context of this invention, a broad range of thickening agents can be used, but preferably those thickening agents are used which do not cause additional skin and/or wound irritation. Examples of suitable thickening agents are those which are used in foods and cosmetics, for example, waxes such as Candelilla and Carnauba wax, microcrystalline waxes, carbomers for example Carbopol® or Novethix ®, polyethylene oxide thickeners, glucamates, polaxameres, cellulose derivatives such as hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hypromellose, povidone, hyaluronic acid, polylactic acid and derivatives thereof, and mixtures of two or more of the afore mentioned compounds.

In order to counteract the growth of micro-organisms upon storage of the composition of this invention, the composition of this invention is preferably stored in a closed volume. More preferably, the composition of this invention comprises one or more preservatives. A wide range of preservatives can be used, particularly suitable are those used in cosmetic preparations. A suitable preservative is for example DMDM hydantoin, or methyl paraben, but also thiazolinone compounds are suitable. However, other preservatives well-known to the skilled person can also be used. These preservatives preferably also have a disinfecting action.

The composition of this invention preferably has a pH between 7.0- 9.0, in order to ensure that upon contact with chemicals having an acidic pH a neutralization to a pH may be achieved which is approximates as closely as possible to the pH of an ordinary skin, and to minimize the risk that the composition in itself would give rise to the occurrence of chemical burns. The pH is preferably chosen such that no adverse effects are achieved on the surface to be treated, and that still the intended effect of the composition is achieved. The pH values described above will normally not adversely affect the pH of the skin. Preferably, the composition of this invention has a pH of between 7.5 and 8.7 or between 7.5 and 8.5 or between 8.0 and 8.5, more preferably between 8.2 and 8.3 The inventors have in fact found that within this range there is a minimal risk to the occurrence of thermal effects upon contact with the chemicals which are to be removed, and that the desired pH can be achieved with a minimal amount of the composition and an optimal buffering rate is obtained. However, depending on the pH of the chemicals with which the skin has come into contact, also a composition having a somewhat higher pH can be chosen if the chemicals have a lower, more acidic H, or a composition having a somewhat lower pH if the chemicals have a higher, more alkaline pH.

In order to be able to obtain the desired pH, and to effectuate neutralization with respect to both acidic and alkaline contaminating chemicals, the composition of this invention contains an amount of a buffer. Preferably use is made of a boric acid/tetraborate buffer, more preferably a boric acid/sodium tetraborate buffer. Sodium borate is a compound which corresponds to the formula:

In order to ensure possible an optimum distribution over the skin or the body part or surface to be treated, the composition of this invention may contain a foaming agent. Suitable foaming agents are known to the skilled person and include ionic or non-ionic surfactants or detergents, including lauryl sulfates, such as sodium lauryl sulfate and ammonium lauryl sulfate, lauryl ether sulfates, but other foaming agents may suitably be used as well.

This invention also relates to the use of a composition as described above for the preparation of an agent for preventing the occurrence of chemical burns of the skin and/or eyes of humans or animals.

This invention further relates to the use of a composition as described above for preventing the occurrence of chemical burns. Preferably, a surface that has possibly been contaminated with one or more chemicals is rinsed or contacted with the composition as described above. The surface may be the skin of a living being, for example, human or animal, clothing, or any other surface. The composition of this invention is particularly suitable for use with humans and animals.

This invention also relates to a method for neutralizing chemicals, in particular chemicals with an acidic or alkaline pH, present on the skin or in the eyes of humans or animals, or present on clothing or on or in the tissue of the clothes, or on a surface of an arbitrary object. This method is characterized in that the surface is contacted with a composition containing water, a boric acid/tetraborate salt buffer for adjusting the pH of the composition between 6.5 and 9.0. The composition is further characterized as described in this patent application.

This invention further relates to the use of a composition as described above, for the preparation of an agent for preventing, reducing the severity of and / or treating chemical burns.

This invention also relates to the use of a composition as described above for the preparation of an agent for the rinsing of the eyes for preventing, reducing the severity of and/or treatment of irritation, burns or other wounds as a result of a possible contact with chemicals. The wording chemicals shall be understood to mean according to this invention, inter alia, acids bases, herbicides, insecticides, detergents, etc.

This invention also relates to a device for applying the composition described above to a surface which has been in contact with, or where there is a risk of contact with one or more chemicals, with the purpose of preventing, reducing the severity of and/or treating of burn wounds. A device according to the present invention for the application of a composition for the treatment and/or prevention of burns preferably comprises a recipient within which a composition as described above is contained, wherein the recipient is provided with means for expelling, preferably expelling the composition under pressure through an outlet opening provided in the recipient.

According to this invention, various devices can suitably be used. In a first preferred embodiment, the device of this invention comprises a collapsible recipient or bottle made of a plastic material and provided with an outlet opening, so that upon manual compression of the recipient or bottle, the treatment composition is expelled through the outlet opening. Such a recipient is particularly suitable for the treatment of small surfaces and skin surfaces. In an alternative embodiment, the recipient or bottle is provided with a plurality of small outflow openings and the aqueous composition can be applied to the skin by distributing it through the openings.

In a second embodiment, the device of this invention comprises a recipient of a large volume, which contains the composition of this

invention. The recipient is provided with a connector along which the composition as described above is permitted to flow in the direction of a spray nozzle with the purpose of distributing of the composition over the skin surface to be treated. Such a shower apparatus is particularly suitable in case larger areas are to be rinsed, for example, a person or object in its entirety, for example a person or object in its entirety, for example the majority of or substantially the entire clothing of a person, and in case large volumes of the composition are needed. Expelling from the container can be done by gravity or under increased pressure.

In a third embodiment, the device of this invention is an apparatus which contains a recipient within which a first container is positioned which contains the composition as described above, wherein the recipient further contains a propellant gas under pressure for expelling the composition when opening the first container, in the direction of an outlet opening of the container, for delivering the composition to the surroundings. In the device of this invention any propellant considered suitable by the skilled person can be used, such as, for example, carbon dioxide. Preferred are those propellant gases that do not cause additional irritation of the skin.

Depending on the volume of the recipient the device may be portable or not. In order to prevent the body portion that is being treated with the composition of this invention, from being subjected to a too high

temperature shock upon contact with the composition of this invention, the device of the present invention preferably includes means for adjusting the temperature of the composition. More preferably, the device of this invention is provided to preserve the composition of this invention at a temperature above the freezing point, preferably of at least 5°C, preferably between 10-40°C, preferably 10-35°C. Such a composition may provide some cooling effect, without causing too great a temperature shock.

According to an alternative embodiment, at a position on or in the outlet for dispensing the composition of this invention, heating means are provided for heating the composition during release.

According to a further suitable embodiment, the device according to the present invention comprises a carrier and the composition of this invention as described above is applied to this carrier. Preferably, the carrier is impregnated with the composition described above. Within the scope of this invention a wide variety of carriers known to the skilled person can suitably be used. The carrier may for example be selected from a sheet, a fabric, a gel or a combination thereof, which has been impregnated with the composition of this invention as described above, or is blended with the composition of this invention for example. Such a carrier is positioned on the surface that has been contaminated with the chemicals, for example on top of the skin, with the purpose of assuring a prolonged contact. The amount of composition present in or on the carrier may vary within wide limits, taking into account the nature of the carrier. Such an impregnated carrier will usually be stored in a resealable bag.

The invention is further illustrated with reference to the attached figures and description of the figures.

Figure 1 shows the variation of the pH of a solution of 1 ml of H2SO4 (minimum 95%) as a function of the administered volume of (A) water

(B) Diphoterine, such as commercially available from Prevor,

France

(C) the composition according to the present invention.

The horizontal line at pH 5.5 represents a physiologically acceptable pH.

Figure 2 shows a preferred embodiment of a device according to the present invention.

The apparatus of this invention shown in Figure 2, is a portable device which comprises a recipient 1, for receiving the composition of this invention, 10 as described above. The recipient is provided with an outlet 6 through which the composition exits the container and can be released to the environment. Preferably, the outlet 6 is provided with a flexible hose 3, which forms a lance, so that the direction in which the composition is expelled can be controlled. The end of the flexible hose is preferably provided with a diffuser 4, so that the liquid composition may be exempted in a finely divided form. Furthermore a seal 9 is provided, which when opened or removed ensures that the propellant gas 8 is released for the expulsion of the liquid composition from the recipient 10 to the outlet 6 and discharged into the environment.

The invention is further illustrated with reference to the examples below.

Comparative experiment A.

The buffer capacity of Diphoterine was tested by titrating a volume of 25 ml thereof with respectively an acid and a base:

(A) by titrating Diphoterine with 0.1 N HC1 to a pH of 6

(B) by titrating Diphoterine with 0. IN NaOH to a pH of 9

(C) by titrating Diphoterine with 0.1 N HF to a pH of 6

The result is summarized in Table 1 below. Example 1-3.

Comparative experiment A was repeated 3 times (1, 2, and 3 in the table below), this time with a composition of this invention containing 1.15 wt. % of boric acid, 1.15 wt. % of sodium borate, 0. 08 wt. % of methyl paraben and completed up to 100 wt. % by addition of water. The results are summarized in Table 1 below.

.Sol l it inn 1 2 3 A pH 8.4 8.4 8.3 7.4

(a) ml 0.1 N HC1 needed to achieve a pH = 6.0 45.1 45 46 7.7

(b) ml 0.1 N NaOH needed to achieve a pH= 9.0 25.2 25 25 9.8

Conductivity (mS/cm) 7 28

(c) ml 0.1 N HF needed to achieve a pH = 6.0 48.0 11.6

From Table 1 above show that the composition of this invention of the Examples 1, 2 and 3, exhibits a significantly higher capacity for the buffering of a strongly acidic and a strongly alkaline solution in comparison with Diphoterine of comparative experiment A. In particular, the examples show that with the composition of this invention, a substantially larger amount of acid/base is necessary in order to arrive at the predetermined pH in comparison with Diphoterine where a relatively small amount of acid/base is sufficient to reach the desired pH. This example therefore shows that the buffering action of the composition of this invention is considerably better than that of the compositions known from the state of the art. This example also teaches that the buffering action of the composition of this invention proceeds substantially faster than that of the state of the art from the known compositions.

Figure 1 below shows the evolution of the pH as a function of time, for the composition of this invention, water and Diphoterine. This figure shows in particular that the neutralization process achieved with the composition of this invention proceeded faster than when using the compositions known from the art. This is important in the prevention of burn wounds, since the risk to the occurrence of burn wounds as well as the severity of the burn wounds significantly increases with increasing contact time.

Table 1 further shows that the conductivity of the composition of this invention is significantly lower than that of Diphoterine, which is a measure of the salt concentration. The lower salt concentration provides the advantage of a better dissolving capacity.