MX2008013076A - Non-synthetic low-protein rubber latex product and mehtod of testing. - Google Patents

Abstract

The present invention discloses a non-<i>Hevea</i>, non-synthetic, low-allergenic, low-protein latex product that conforms to the standards published by the American Society for Testing Materials for <i>Hevea</i> latex products, and a new method and standard for determining the qualitative and quantitative properties of such products, including the substitutability of and superiority to <i>Hevea</i> and synthetic latex products.

Description

LATEX PRODUCT OF LOWEX PROTEIN NON-SYNTHETIC RUBBER AND TEST METHOD FIELD OF THE INVENTION The invention described herein relates to a natural latex product derived from plant materials. More specifically, the invention relates to a latex low allergenicity and low protein product, non-synthetic, which is not Hevea, made from desert plants native to the southwestern United States and Mexico, including the guayule plant. (Parthenium argentatum), and a method of testing the properties of such products to determine quantitative and qualitative substitution for and superiority to Hevea, and synthetic latex products for use in medical devices, in industrial uses and for consumer products .

BACKGROUND OF THE INVENTION Natural rubber, derived from the Hevea brasiliensis plant, is a key component of many industrial products such as coatings, films, and packaging. Natural rubber is also widely used in medical devices and consumer items. More specifically, latex is used in medical products that include; gloves, catheters, laboratory test equipment, tests, disposable kits, drug containers, syringes, valves, seals, ports, plungers, forceps, drippers, plugs, bandages, dressings, examination sheets, wrappers, covers, tips, guards and covers for endo-devices, solution bags, balloons, thermometers, spatulas, flexible tubing, bonding agents, storage and transfusion systems, needle covers, turnstiles, tapes, masks, stethoscopes, medical adhesive, and latex products for the care of wounds. The uses of natural rubber after procedures in patients include: compression bands, ties and bands, inflation systems, trusses, splints, cervical necks, and other support devices, belts, clothing and wheelchair cushioning and crutches. Natural rubber is also used in many other common household products such as pacifiers, rubber bands, adhesives, condoms, disposable diapers, art supplies, toys, baby bottles, chewing gum, and electronic equipment, to name but a few.

However, the wide use of natural rubber is problematic for several reasons. First, the vast majority of natural rubber derived from Hevea grows from a limited number of crops in Indonesia, Malaysia and Thailand, using labor-intensive harvesting practices. Rubber and products made from Hevea are expensive to import to other parts of the world, including the United States, and supply chains may limit the availability of materials. Additionally, due to the area of restricted growth and genetic similarity of these crops, plant blight, disease or natural disasters have the potential to sweep the bulk of world production in a short time.

Second, particularly in the areas of health care and patients, an estimated 20 million Americans have allergies to the proteins found in the natural rubber crop derived from Hevea of Southeast Asia. Like many other plants, Hevea produces proteins for structural support and for purposes related to defense in response to environmental conditions. However, there are at least 62 known Hevea antigens involved in Type I latex allergy, and more than a dozen of these latex proteins derived from Hevea are common human allergens, including: Hev bl, and Hev b3 used in the rubber biosynthesis, defense-related proteins Hev b2, Hev b4, Hev b6.01, Hev b6.02, Hev b6.03, Hev bl.01, Hev bl.02, Hev bll, and Hev bl2, and other proteins such as Hev b5, Hev b8, Hev b9, and Hev blO.

An allergic response to Hevea begins when an individual allergic to latex is exposed to these proteins, triggering the production of immunoglobulin E ("IgE") antibodies. IgE antibodies elicit a variety of responses, depending on the severity of the allergy. Typically, latex allergies are limited to skin inflammation, but serious reactions and even death may occur in some individuals. Additionally, the structures of these proteins have also been evolutionarily conserved in many plants, not just Hevea, making individuals allergic to Hevea susceptible to similar proteins in other plants ("cross-reactivity"). It is also likely that the human Hevea culture has inadvertently selected the presence of allergenic proteins that function as common epitopes (antigenic sites in the protein) for the production of immunoglobulin E antibodies in individuals allergic to latex, making the effective removal of such proteins. Generally, the potential allergenicity of a latex product is determined by measuring the known IgE antigenic proteins, the overall levels in the proteins, and determining the cross-reactivity in particular plant species to the known IgE antigenic proteins. Products with lower amounts of known IgE antigenic proteins are less likely to trigger the production of immunoglobulin E antibodies in a person allergic to latex. Therefore, products with low numbers and levels of known antigenic IgE proteins have substantially decreased allergenicity.

In addition, the more proteins present in a latex, the greater the likelihood that humans exposed to one or more of these proteins become sensitized, thus developing an allergy to it. Thus, reducing the protein content in latex products, especially proteins that are common human allergens, is the first step in reducing the overall number of subsequent allergic reactions.

The specific sensitivity to proteins varies among individuals allergic to latex, and therefore, to lower the overall risk of the allergic reaction, lower levels of overall protein are desirable. Products with low protein levels are generally less likely to elicit an allergic response and are thus substantially less allergenic than products with higher protein levels. Hevea latex products are made from latex that typically contains more than 9,000 g of total protein per gram of dry weight latex, including the aforementioned antigenic proteins; and the higher the total protein per gram of dry weight, the more likely the allergic reaction.

There are also several non-Hevea plants that are known to cross-react with individuals allergic to Hevea. These plants contain similar types of structural support and plant proteins related to defense and can 'produce similar allergic responses in humans. These types of plants are much less likely sources of a low-allergen natural rubber alternative for Hevea.

In general, the broad penetration capacity of latex allergies in the population of E.U. It is expensive, particularly in the medical area. To avoid unnecessary allergic reactions during medical procedures, providers must ensure that only alternative latex products come in contact with a latex-allergic patient. Additionally, practitioners who present themselves with latex allergies should ensure that they do not come into contact with products based on natural latex. Finally, synthetic rubber alternatives are often much more expensive or not available in non-Hevea latex forms. Therefore, there is a need for low-protein, non-synthetic natural rubber latex products that are qualitatively and quantitatively suitable for the replacement of, or are superior to existing Hevea or synthetic latex products.

Generally, latex extracted for medical or industrial uses is tested to meet the standard specifications of various regulatory bodies, including the American Society for Testing Materials ("ASTM"). Each type of latex product is given a "type" ASTM. For example, Type I includes centrifuged Hevea latex preserved with ammonia alone or formaldehyde. Type II latex is Hevea latex that has been cremated and preserved with ammonia alone or by formaldehyde followed by ammonia and Type III latex is centrifuged latex from Hevea preserved with low ammonia or other preservatives. Latex products of Type I, II and III are tested in accordance with the respective standards I, II, or III of ASTM D 1076-02. See Table 1.

ASTM Property Product Product Product Standards Latex TYPE I Latex TYPE II Latex TYPE D1076-02 III Color and Odor None None None pronounced pronounced pronounced Content of 63.1 66.0 61.3 Total Solids (% min) Content of 59.8 64.0 59.8 Dry Rubber (% min) Content of 2.0 2.0 2.0 total solids less dry rubber content (% max) Alkalinity 0.60 min 0.55 min 0.29 max Total (ammonia as% latex) Stability 650 650 650 mechanics @ 55% TSC, seconds Copper (% max of 0.0008 0.0008 0.0008 total solids) Manganese (% max 0.0008 0.0008 0.0008 total solids) Content of 0.10 0.10 0.10 sludges,% max Content of 0.050 0.050 0.050 clot,% max KOH number, max 0.80 0.80 0.80 Table 1 ASTM D 1076-02 provides a table of standards, listing a number of physical or chemical properties, for Type I, II and III latex products as shown in Table 1. Each of these properties it is associated with a standard numerical value or standard written value to indicate the minimum or maximum standard quantity allowed for a latex product to meet the requirements for that type. The written values of the standard provide a method of quantification where measurement by a standard numerical value is difficult or impossible (for example, the words "absent" or "present" are written values). Each of the properties is measured according to standard methods, as required by ASTM D 1076-02 and given a detected numerical value, or a detected written value, based on experimental results. These written values detected or. The numerical values detected are then compared with the standard numerical value and the standard written value for each property. After all properties are tested, compliance with ASTM D 1076-02 can be determined; and if all properties meet the standard numerical or standard written values, the latex will be in compliance with ASTM D 1076-02.

However, even synthetic or Hevea latex products that can meet these standards have recalcitrant problems when used in medical products and in the medical device industry. As discussed in detail above, Hevea latex causes sensitization and allergic reactions. In many of these end-use applications, the additional replacement of Hevea latex with synthetic polymers is an inadequate solution because these synthetic polymers often fail to perform as needed.

Thus, ASTM D1076-02 is insufficient to determine the physical or chemical properties of natural latex that is not Hevea, because it only goes to Hevea latex. Therefore, there is also a need for a method and standard for determining the chemical or physical properties of a source of natural rubber of local production, without cross-reactions, of low allergenicity, low protein, of higher quality, which can be used to evaluate quantitatively and qualitatively the replacement capacity and superiority of a natural rubber latex alternative that is not Hevea for use in medical, industrial, and consumer applications and products.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an immunostaining image that compares Hevea latex and latex proteins that are not Hevea.

FIG. 2 is a graph detailing the tension stress of gloves with Hevea latex and films for guayule latex gloves with variable sulfur content.

FIG. 3 is a graph detailing the elongation at the levels of breaking in gloves with latex from Hevea and guayule latex films with variable sulfur content.

FIG. 4 is a graph that details the viscosity of guayule latex and Hevea latex as measured by a viscometer in rotations per minute (RP). FIG. 5 is a graph detailing the mechanical stabilization of guayule latex in the presence of different amounts of two stabilizing compounds. FIG. 6 is a graph detailing the elongation to the breakage of aged and unadded films of guayule latex at various sulfur contents, compared to aged and unpainted Hevea latex films at comparable sulfur contents.

FIG. 7 is a graph detailing the modulus properties of aged and unadded films of guayule latex at varying sulfur contents, compared to aged and un-aged Hevea latex films at comparable sulfur contents.

FIG. 8 is a bar chart detailing the various properties of aged and un-aged guayule latex films, compared to aged and un-aged Hevea latex films, compared to the specification of ASTM D3577-01 for Gloves of Surgical rubber.

FIG. 9 is a graph comparing the physical properties of guayule latex films and Hevea latex films.

Figures 10A and 10B are graphs comparing the stretching-relaxing properties of guayule latex films and Hevea latex films.

FIG. 11 is a flow diagram illustrating three options for the hydrogel coating of guayule latex gloves.

DETAILED DESCRIPTION OF THE INVENTION The present disclosure is directed toward a non-synthetic non-synthetic latex product of Hevea that conforms to the specifications of Type I, Type II, or Type III latex products by the American Materials Testing Society (" ASTM "). The present disclosure further provides a method for determining the properties of a non-Hevea natural latex product in order to evaluate the substitutability of natural non-Hevea latex products for existing Hevea and synthetic latex products, as well as to demonstrate The superiority and advantages of latex product low in allergens and low in proteins, not synthetic not Hevea. The method described provides a new standard for a natural rubber latex that is not Hevea (for ease of reference, it is referred to herein as "Guayule Standard"). A summary of the Guayule Standard is shown in Table 2. In addition, the product described herein is a product that meets or exceeds standards for the physical and chemical composition of a natural rubber product that is not Hevea in accordance with the recently developed Guayule Standard and described herein as shown in Table 2 below.

Standard Standard Property of Guayule Latex Color and Odor White colorless to beige / moderate smell to ammonia Total Solids Content (% 40-62 for commercial viability) (see example 5) Dry Rubber Content (% for 38-62 commercial viability) (see example 5) Total solids content 0-2 less dry rubber content (% ) Total Alkalinity (0-0.8 potassium hydroxide as% latex) (see Example 8) Total protein by D5712 0-200 (microgram / gram dry weight latex) (see Examples 4 and 7) Hevea antigenic protein None by D6499 ((micrograms / gram of dry weight latex) (see Example 4) pH (%) (see Example 13) 7.0-13.0 Mechanical stability @ 43% TSC, 90-400 seconds (see Example 14) Copper (% solids) 0-0,0008 total) (see Example 15) Manganese (% solids 0-0,0008 total) (see Example 15) Sludge content, (%) (see 0-0.10 Example 10) Clot content, (%) (see 0 -0.050 Example 11) KOH number, ma (see Example 12) 0-0.80 Table 2 Examples of natural rubber sources that are not Hevea include, but are not limited to, guayule. {Parthenium arge ntatum), tartago (Euphorbia lathyris), mariola. { Parthenium incanum), "rabbitbrush" or rabbit tail (Chrysothamnus nauseosus), milkweeds (species Asclepias), goldenrods (species Solidago), pale banana of India (Cacalia atrípilcifolia), rubber vine or cucumecate (Crypstogeia grandiflora), Russian dandelion (species Taraxacum and species Scorzonera), mountain mint (Pycnanthemum incanum ), American average. { Teucreum canadense) and high Campanula. { Campanula america). All these sources of natural rubber that are not Hevea can be evaluated according to the described method to determine the suitability of use in low allergen, low protein, non-synthetic, latex products, described.

In particular, the guayule. { Parthenium argentatum), a desert plant native to the southwestern United States and northern Mexico, produces essentially identical polymeric isoprene, or improved latex quality, when compared to Hevea latex. Thus, the terms of natural rubber latex that is not Hevea and guayule latex are used interchangeably in the present disclosure. Additionally, processed guayule latex has no proteins that contribute to the allergenic properties of Hevea latex. The natural rubber polymers in guayule latex have a high molecular weight and, therefore, products made from this material can be used in high performance applications.

In its natural state, the sap of the guayule plant is not low in protein. However, a low protein natural rubber latex can be extracted from the guayule with several processing steps. The low protein guayule latex is produced by removing the rubber particles from the intact cells of the parenchyma of the guayule plant in an aqueous suspension. The plant remains in a hydrated state until processing, where it is homogenized in an aqueous alkaline extraction medium. The rubber particles, which have a specific gravity slightly less than 1, are then purified from the homogenate by using a series of centrifugation and / or flotation steps with creaming agents. This process results in a natural rubber latex with very few soluble or cytoplasmic protein components remaining. Additionally, various stabilizers and additives can be used to modify the physical properties, storage duration, or quality, depending on the desired uses. For example, the addition of sulfur can change the flexibility or "relaxation" of the material by creating a sulfur crosslink between the existing latex polymer chains. Other chemical or stabilizer additions can also be added to the guayule latex depending on the desired use. In general, purified guayule latex can remain stable for extended periods and can be used to make a wide variety of products, including products with low allergenic content for medical use.

Guayule latex has many potential applications in the medical products market due to its low allergen properties. The properties include: (1) very little protein, less than about 200 micrograms (yg) of protein / gram (g) dry weight latex in the whole; (2) without detectable levels of some known antigenic proteins of Hevea IgE; (3) the remaining limited amounts of protein are hydrophobic and bind to the rubber phase, which limits the likelihood of absorption into human skin, tissues or extraction within body fluids; and (4) none of the protein present in guayule latex cross-reacts with latex allergies for Hevea latex products ("Type I" latex).

Guayule latex is also not likely to cause latex sensitivity in the long term or extensive allergic reactions over time, for a variety of reasons. Historically, well-leached Hevea latex products were widely used in the medical industry for many decades to protect against the transmission of diseases are to cause allergies to Type I latex, and these products contained much more protein, more than 45 times those of guayule latex products. When human exposure to the product increases, especially to poorly leached products with high levels of soluble protein, a large percentage of the population begins to develop allergies. This is unlikely to happen with guayule, which does not contain soluble proteins in the latex. Guayule latex products, as described herein, also have the physical advantages possessed only by natural rubber materials, and medical products made thereof meet or exceed ASTM D3577-01a physical property standards for products. of Hevea that could not be reached by the synthetic polymeric materials. These properties are also related to product safety because they improve the strength and elasticity of latex films as well as the fit and feel of products, such as surgical gloves.

First, the guayule latex products, according to the present disclosure, contain very little soluble protein, because they are produced by purification of the rubber particles from a plant homogenization.

Unlike Hevea latex, guayule latex must be purified before use. This process removes the components of the plant that are not rubber, including soluble proteins, as well as water-soluble plant pigments. Guayule latex that has not been sufficiently purified will contain high levels of green and brown dyes. These dyes provide visual clues to the quality and level of soluble protein in latex. Colored latex will be of lower quality, insufficient to generate a high performance latex and will have a higher level of soluble proteins.

Second, according to the present disclosure, guayule latex products contain approximately 90 times less total protein than Hevea latex at the same dry weight. Third, guayule latex products are processed without the need for protein-reducing leaching stages, because guayule latex products are very low in soluble proteins. Most of some remaining proteins are insoluble or hydrophobic which means that the product will not be absorbed into human skin, as is problematic in Hevea products not leached or poorly leached, where up to 50% or more of the total proteins are hydrophilic or highly soluble. This high solubility is a major contributing factor to the sensitization and eventual triggering of an allergic reaction.

In comparison, the amount of soluble protein present in guayule latex is about 45 times less than even the best leached Hevea latex products. In general, even if only the proteins that bind to the particles were retained after extensive washing with Hevea latex, the Hevea latex would still contain approximately more than 22 times the amount of the total protein in the guayule latex product. described. In general, clinical and performance tests indicate that guayule processing provides a natural rubber latex with low allergens, high performance, safe, that is safe for human use.

The product described herein is a latex low allergen product, with a global purity and composition that generally conforms to the property values of ASTM D 1076-02 for Hevea latex, and which meets or exceeds the properties of the Guayule Standard described herein and shown in Table 2. In addition the guayule latex product described has a Dry Rubber Content (DRC) that is in the range of about 30% to 65% concentration in Water. The property values of the Guayule standard for non-Hevea latex may include: Total alkalinity, KOH as a percentage of latex, copper, manganese, KOH number, total solids content, dry rubber content, viscosity, content of sludges, clot content, mechanical stability, density, color, odor, protein content and volatile fatty acids.

In at least one embodiment, the described product conforms to all the requirements of the guayule standard currently described. In addition, the described product has very low allergenicity and is for use in humans with latex allergies. Additionally, the product prevents sensitization to allergens, in which even humans with latex allergies are unlikely to be sensitized to any of the few proteins present in the product-thus they are less likely to develop a new allergy. In other words, the product has no detectable Hevea antigenic proteins and low overall protein levels, based on assays using standard detection methods.

For example, these standard detection assays may include immunological measurement of antigenic protein content by using the standard protocols of ASTM D6499, ELISA inhibition assays using the standard protocols of ASTM D6499, total global protein levels when using the assays Modified Lowry using the ASTM D5712 standard protocols, and backup subtraction techniques when using ASTM D5712 standard protocols. More specifically, compliance with the latex requirements for the currently described Guayule Standard includes a product with less than 200 micrograms (μ?) Of total protein per gram of dry weight latex, when measured by protein analysis that is extracted in aqueous detergent. The Guayule Standard described for non-Hevea latex also includes detectable low levels of soluble protein and the absence of known antigenic proteins that cross-react with IgE antibodies which trigger allergies to Type I latex.

In various modalities, the product can be used in a variety of medical, consumer and industrial products. For example, in one embodiment, the product is a non-synthetic latex product, low in allergens, which is not Hevea formed in a film. Generally speaking, the formation of a latex film requires the coalescence of the individual latex particles by the evaporation of the continuous phase (aqueous phase) of the latex material at specific temperatures. Structurally, during evaporation, the electrostatic or spherical forces that keep the latex particles separated are overcome when the terminal groups of charged polymer chains or surfactants are removed. The resulting film is formed by a polymer lattice, with various physical properties depending on the evaporation conditions. Example 1 provides a method of producing a film, an example of a product that meets the Guayule Standard currently described. Example 1. Dry Movies Homogenous, dry, air-free films are prepared from concentrated lattices that are not Hevea, such as guayule. A mold is constructed by cementing rigid plastic strips of 6 millimeters (ram) of width 1.5 of thickness on a flat glass plate to form a cavity surface preferably having from 125 to 150 square mm. Dry films of 1 mm thickness will result when the mold is filled with latex at 62% total solids content (TSC) and around 0.7 mm can be produced with 48% latex of TSC: then tests are made to compare Hevea latex films and those that are not Hevea according to standard techniques, following ASTM D1418 and D1566 Standards.

In one embodiment of the film preparation, the mold is formed by the cementation of plastic strips to a glass plate with epoxy resin adhesive or polyvinyl acetate dissolved in methyl ethyl ketone. A stainless steel or wood trimmer is used to scrape the latex surface in the mold free from air bubbles. Thin transparent cellulose film sheets are used to cover and protect the dried rubber films.

The film is prepared without dilution if the TSC is about 62% or less. If the TSC is higher than 62%, the latex is brought to this value by dilution with distilled water. The latex is mixed well in the sampling bottle and allowed to stand for five minutes. The latex is then carefully poured through a 180-ml stainless steel mesh with a minimum aperture of 0.180 ± 0.009 mm (0.0070 ± 0.0004 inches) into a covered 50 ml glass beaker and allowed to stand for five minutes before emptying it into the mold. The mold is placed in the position in which the film will be allowed to dry. Immediately before pouring the latex into the mold, remove the cover of the beaker and scrape the foam-free latex surface with a piece of filter paper. By keeping the beaker close to the plate, the latex is emptied into the mold in a continuous stream, distributing the latex evenly in the mold cavity to fill the mold completely. The latex is left to rest in the mold for one minute and then a clean wooden or stainless steel scabbard is scraped through the mold.

In this method of preparing the film, the cast material is allowed to dry first at room temperature, and then in an oven at a temperature not exceeding 35 ° C. When the film is sufficiently dry to remove it from the mold without distortion, the film is removed from the mold, taking care to handle the surface of the film as little as possible, turning it over and placing it on a piece of thin, transparent cellulose sheet. The film is allowed to stand for at least another 24 hours at a temperature not exceeding 35 ° C and then covered with another piece of cellulosic sheet. The dryness of the film is judged by the clarity, which increases when the film becomes drier. If there is any doubt about dryness with visual examination, the film is dried to constant mass at a temperature not exceeding 35 ° C in a dry atmosphere. The film is stored until it is required to test in a cold, dark place in an airtight container or desiccator to avoid moisture absorption.

In another embodiment, the method is directed to the production of a non-synthetic, low-protein latex glove, which is not Hevea with high elongation properties. For example, in this mode, the glove will have expansion properties that will allow the manufacture of a limited number of sizes without compromising the adjustment to the user's hand. In this example, the glove will stretch to fit a wide range of types and sizes of the hand and will require a smaller number of sizes to be manufactured. In one example of this mode, the dimensions of the glove are based on the size in volume of the hand, not on the length of the hand.

The latex gloves products, according to the present disclosure, include both examination gloves and surgical gloves. Surgical gloves differ from gloves for examination in many ways. Although they are similar in design, the requirements for end use are quite different. Although examination gloves are used for routine, low-demanding procedures (changing a bandage, puncture in the vein, handling specimens, etc.), surgical gloves are used for long surgical procedures which may last several hours. . Thus, surgical gloves must be durable to maintain barrier properties but remain flexible and soft for comfort. Touch sensitivity is critical for the surgical procedure. The properties of elastic recovery are also key due to the delicate procedures when suture or other manipulation is required. Many synthetic materials (such as nitrile) maintain a wrinkle at the fingertips, which impairs sensitivity to touch. Thus, surgical gloves comprising synthetic polymers lack the desired tactile properties necessary to be considered high quality or demonstrate optimal performance.

However, the surgical gloves comprising the non-synthetic latex described herein demonstrate rather superior elastic and tactile recovery properties than those surgical gloves comprising synthetic polymers. As shown in FIGs. 10A and 10B, the measurement of the stretching ratio of guayule latex against Hevea latex from 0-1 minutes (FIG 10A) and then from 0-15 minutes (FIG 10B), results in less relaxation and movement Hevea when stretched over time. Also, the results show that guayule latex imposes less fatigue on a human hand when a glove is worn for a prolonged period of time. In addition, as illustrated below, both the surgical and examination gloves comprising the non-synthetic latex described herein are softer than either Hevea or synthetic gloves, when measured by the latex film module (discussed below). continuation) .

In addition, surgical gloves should be dust-free, dust-free guayule latex gloves films can be produced from a product sprayed by different methods that include (1) Online / Offline Chlorination and (2) Alternative Chlorination Off Line.

For in-line / out-of-line Chlorination, although the glove film is still in shape just after leaving the curing oven, the film is leached after curing (water temperature 40 ° C - 60 ° C), dried moderately to remove moisture from the surface. The films are first immersed in a bath of diluted HC1 solution (maintained between pH 2-5), followed by immersion in a bath of bleach solution (sodium hypochlorite, 3% to 6% solution). Subsequently, the film is immersed in a bath with diluted water or caustic to neutralize the chlorination reagents. By maintaining the parameters at the intervals specified above, the chlorine concentration should be between 500 ppm and 4000 ppm. Reducing the pH of the acid solution will increase the concentration of the chlorine solution, and vice versa.

Alternatively, the HC1 and bleach baths can be replaced by a simple bath consisting of chlorine gas injected into the water to a concentration of 500 ppm to 4000 ppm. This bath would be followed by the water / neutralizer bath. Then the movies would come off completely from the form. The films after the detachment would result with a "grip side". In an off-line chlorination unit, the films would be chlorinated on the grip side producing a completely dust-free glove. Chlorination is carried out by using chlorine gas injected into a stream of water up to a concentration range of 200 ppm to 2000 ppm chlorine.

For the alternative method of Off-line Chlorination, while the glove film is still in the form following leaching prior to curing, the film is immersed in a thick solution of calcium carbonate, which when dried during curing it will become in the powder that facilitates the removal of the film from the form. The glove film is removed from the shape and inverted to the side that is put in order to chlorinate this side first. In an off-line chlorination unit, then the films will be chlorinated first on the side that is put on. Chlorination is carried out by using chlorine gas injected into a stream of water up to a concentration range of 200 ppm to 2000 ppm chlorine. Depending on the application, the films can be inverted to the grip side and be chlorinated a second time on this side. The chlorine concentration range would be 100 ppm to 1500 ppm. After neutralization and rinsing with water, the films are dried to produce a glove completely free of dust.

In addition, the gloves can be coated with hydrogels. As shown in FIG. 11, at least three optional methods of hydrogel coating of guayule latex products are described herein. As shown in FIG. 11, Option 1 is the basic procedure for the application of the hydrogel coating; Option 2 shows an alternative procedure by which the active conditioner of the bonding surface is omitted from the process; and Option 3 includes additional online leaching. The inclusion of this leaching requires that the silicone immersion be moved to a point after additional leaching.

In a further embodiment, the method further includes a step to coat a Hevea or synthetic latex product. For example, in this embodiment, the method includes one or a plurality of layers that cover all or a portion of a Hevea or synthetic latex product. In another example, the method includes one or a plurality of layers that cover all or a portion of an article made from a compound other than the source of natural rubber that is not Hevea, e.g., plastic, metal, wood, ceramic , alloy, and the like. In at least one embodiment of this method, the article is immersed, sprayed or otherwise coated in a guayule latex coating to provide a barrier between the article and the wearer's skin. In other embodiments, the method further includes "sandwiching" the article between the top or bottom coatings of the non-Hevea latex. In a specific additional embodiment, the method includes a final step of dipping or coating a Hevea latex or synthetic latex film (eg, a glove) with a latex that is not Hevea.

In another embodiment, the product targets a low-protein, non-synthetic latex product, not Hevea, for use in medical devices such as catheters, medical adhesives, latex products for wound care, laboratory test equipment, tests, disposable kits, containers for drugs, syringes, valves, seals, ports, pistons, forceps, drippers, plugs, bandages, dressings, examination sheets, wrappings, covers, tips, protectors and covers for endo-devices, balls for solution , balloons, thermometers, spatulas, flexible tubing, bonding agents, storage and transfusion systems, needle covers, turnstiles, tapes, masks, and stethoscopes, compression bands, ties and bands, inflation systems, trusses, splints, collars cervical, and other support devices, belts, clothing and cushioning in wheelchairs and crutches.

Although synthetic materials such as silicone rubber, polyurethane and synthetic polyisoprene are used in some of the hundreds of applications of specialized products for catheters (especially balloon catheters), some of these materials can not maintain a constant pressure when required. In addition, some synthetic products do not have the structural integrity to maintain rigidity for extended periods of time. The bursting of balloon catheters during a surgical procedure can be life-threatening. Medical devices that comprise the non-synthetic latex described, have superior structural integrity and avoid these life-threatening problems.

In an additional mode, the product targets dental tools and products such as dental dykes. The biggest problem with current dental dams is that they are all constructed of Hevea latex. Due to the particular manufacturing process used in the construction of dental dams, Hevea latex can not be properly leached, resulting in a latex product high in soluble proteins. This is extremely dangerous for dental dams which are used as upholstery material for oral procedures and come in close contact with mucosal tissue. Such contact of a latex with high allergens, highly sensitive and poorly leached can result in either a rapid sensitization and / or severe allergic reaction. Due to the low allergenicity of the described dental dams that comprise guayule latex, this danger is avoided.

In yet another embodiment, the product targets barrier devices for birth control, such as condoms, both male and female, diaphragms, cervical closures and contraceptive sponges. Condoms, made with guayule latex in accordance with the present disclosure, are less susceptible to the common breakdown problems that are often encountered with condoms made of synthetic polymers. FIG. 9 graphically details the comparison of the physical properties of guayule latex and Hevea latex. As shown in FIG. 9, although guayule latex has similar tensile properties as Hevea, guayule latex has greater elongation and more elasticity than Hevea latex, thus demonstrating the superior ability to stretch before rupture. Also, the condoms described herein that comprise non-synthetic latex are softer than synthetic condoms, when measured by the latex module (discussed below), and provide greater comfort during use.

In an additional mode, the product targets products and processes for use in non-residential settings such as nursing homes, treatment centers, spas, hospitals, day care centers, clinics, medical and dental offices, day care services, and schools. In this modality, the product may include medical devices or other specific items for the industry or population served.

Still in another modality, the product is directed to industrial products and processes such as extrusions, paints, films, coatings, coatings, construction materials, sealants, packaging, production equipment, transfer equipment and containers. In an additional mode, the product is directed to household uses such as children's items, office supplies, and health and beauty items such as condoms, applicators, cosmetics, and dental care products. In other modalities, the product is directed to storage containers, equipment for food, beverages and electronics. Finally, the product is a low-protein, non-synthetic substitute, which is not Hevea, for any existing product that currently comprises Hevea or synthetic latex.

As described in Example 2, the protein content of guayule latex products, as described herein, is substantially less than that of highly leached latex products from Hevea. Low levels of proteins, which result from a latex washing process which removes all hydrophobic and soluble proteins that do not bind to rubber particles, coupled with the hydrophobic nature of the remaining proteins, decreases the potential for allergic reactions in individuals prone to latex allergy. The remaining hydrophobic proteins are associated with the membranes of rubber particles which, therefore, are far less likely to cause allergic reactions. Additionally, as the following examples illustrate, in comparison with the Hevea latex, the guayule latex product described herein contains rubber polymers of similar molecular weight. In addition, guayule latex forms a very insoluble gel because it is a less branched polymer. Finally, guayule latex products, as described herein, may be more viscous than Hevea latex at any comparable percentage of Dry Rubber Content ("DRC"). However, any difference in viscosity that can be observed can be overcome with additives such as surfactants. The guayule latex products also have a substantially lower protein content, and have similar flexibility and strength characteristics. Example 2. Comparison of Physical Properties of Glove Films with Guayule Latex and Hevea Latex Guayule latex gloves films are made by using the following protocol. A glove former was preheated to 75 ° C and immersed in a coagulant comprising 17% CaNC > 3, 4% CaCO3, 0.2% of surfactants at 45 ° C without any residence time. The coagulant was dried for one minute at 75 ° C. The above is then immersed in a composite latex (33% TSC, room temperature) with a residence time of ten counts to form a film. The film coated formers are dried for six minutes at 75 ° C, rolled into beads to form a fold, and then leach for two minutes at 50 ° C. The films are then cured for fifteen minutes at 110 ° C, removed from the previous one and chlorinated. The physical composition and content are then measured for guayule latex gloves films, made as described above. Guayule latex films are measured compared to commercially available latex glove gloves made of Hevea latex gloves, using standard techniques for measuring pigment, modulus, tensile stress and elongation at break. Mechanical stability and viscosity are previously measured in the guayule latex itself. 1. Stress strain: Eight replicas of gloves with Hevea latex are compared with eight replicas of guayule latex gloves with different percentages of sulfur concentration. The tension samples are cut to 10 mm wide, perpendicular to their direction in the form, and tested in accordance with the standard techniques described below. As shown in FIG. 2, Hevea latex gloves have a final tensile stress of 22-30 megapascals (MPa), while guayule latex gloves show that strain levels increase when the sulfur content increases . 2. Swelling: Swelling tests are also performed using standard techniques to measure linear swelling in guayule latex gloves containing various sulfur contents. The swelling of the guayule latex film is then compared with the published standards for Hevea latex at various vulcanization levels. As shown in Tables 3 and 4, the complete state of the cure can be obtained by using rubber chemistry tailored to the desired properties of the guayule latex. The results indicate that guayule latex films without aging will reach a state of curing of the laminate without further processing.

Swelling in guayule latex gloves is comparable to Hevea latex product standards. As shown in Tables 3 and 4, the linear swelling tests for Hevea latex films have values greater than 160% for unvulcanized films, 100-159% for lightly vulcanized films, 80-99% for moderately vulcanized films. , and below 80% for fully vulcanized materials.

Table 3 phr S Films with Latex Films with latex from Guayule Hevea Unpainted Aged without aged yellowing 0.5 100 96 84 72 1.0 92 84 80 72 2.0 82 80 76 68 3.0 80 80 76 68 Table 4 3. Viscosity: A viscosity comparison between the Hevea latex and guayule latex is made by using the plate-to-plate and viscometer geometry techniques.

Plate-to-plate rheometry is performed when using techniques standard known in the art. The test with a Viscometer is made by using a Brookfield viscometer LVDV-II + (Brookfield Engineering, Inc., Stoughton, MA) in which the viscosity is measured by the resistance to a spindle Rotary The results of the experiments in the viscometer indicate that the guayule latex is more viscous that Hevea latex in some percentage in particular DRC, measured in centipoises (cps), as shown in FIG. 4. The higher viscosity, which is attributed to a larger particle size of the latex, can result in a process of immersion improved, in terms of a collection improved, shorter residence time and more speeds fast online. However, it is also possible with the addition of suitable additives, such as surfactants, to reduce the viscosity of the guayule latex, if desired. 4. Mechanical Stability The rubber particles of the guayule latex have an average particle size of about 1.4 μm in contrast to the Hevea particle diameter of about 1.0 μ ??. The differences in the size of particular are attributed to a higher latex viscosity and lower TSC in guayule latex compared to Hevea latex. The mechanical stability of the latex film lattices can be measured by using the procedures of ASTM D 1076-02 where TSC exceeds 55%. However, to compensate for this, the guayule latex with TSC of less than 55% is measured by using the techniques described below. The mechanical stability of both lattices at a similar% TSC gives comparable results, as shown in FIG. 5. Guayule latex samples tested at a TSC value of 43% had mechanical stability times (MST) of up to 370 seconds. "Comparatively, Hevea latex samples at 62% TSC had MST values of approximately 1,175. Hevea latex at 46% TSC has MST values of approximately 130 seconds 5. Elongation at Breaking: Elongation properties at breakage of guayule latex without aging (NRLG without aging) and aged guayule latex (NRLG aged) at varying sulfur contents are compared with Hevea aged latex (aged NRLH) and Hevea latex without aging (NRLH without aging) at comparable sulfur contents when using standard techniques of elongation at break, as shown in FIG.

In one experiment, eight replicas of gloves with Hevea latex are compared with eight replicas of guayule latex gloves with varying sulfur contents. As shown in FIG. 3, Hevea latex gloves have elongation at 700-800% break, while guayule latex elongation levels correlate with sulfur content. In another set of experiments using standard techniques of elongation at break, guayule latex films, as shown in FIG. 6, they exceed the ASTM D3577 Surgical Glove Standard even at the highest sulfur level of 3 phr (sulfur content) and have an elongation at the top break when compared to Hevea latex. The high values of elongation at breakage of guayule latex films indicate a high level of stretch in these films. Comparatively, synthetic latex gloves have a tensile stress of approximately 25-35 MPa and an elongation at break of approximately 550-675%. 6. Module: The properties of a continuous film depend on the formation temperature and the additives which affect its elastic modulus, or resistance to particle deformation. The elastic modulus of a film affects its application, and generally a moderate level of the module is appropriate for uses such as latex gloves (as indicated in ASTM D3577). The module reflects the strength of the film combined with its softness and feel to the touch. Films with a high modulus have a tendency to crack and crack, while films with a very low modulus are sticky and are suitable as adhesives.

The modulus properties of guayule latex without aging (NRLG without aging) and aged guayule (aged NRLG) at variable sulfur contents are compared with aged Hevea latex (aged NRLH) and non-aged Hevea (NRLH without aging) at comparable contents of sulfur using standard techniques. As shown in FIG. 7, non-aged guayule latex films reach a maximum of 2 phr of sulfur, which indicates an optimal ratio of the compound to sulfur. These non-aging films of guayule latex have almost as high a crosslink density as the films with 3 phr, as shown in Table 5. As shown in FIG. 7, the maximum module at 2 phr indicates a maximization of the mono-sulfhydric bonds compared to those films with 3.0 phr of Hevea latex without aging. The additional sulfur content allows more poly-sulfide bonds between the latex polymer chains, resulting in a lower modulus. The aged guayule latex films are even milder than the non-aged Hevea films except the higher sulfur content. Hevea films are consistently less smooth than guayule films at all sulfur levels. Hevea films fail in ASTM D3577 Standard, at the highest sulfur content, while guayule latex films still meet or exceed ASTM standards.

In general, the results indicate that the guayule latex product outperforms synthetic materials, and has physical properties at least comparable to the Hevea latex, as shown in FIG. 8. Additionally, guayule latex products meet or exceed ASTM D3577 Standards for surgical gloves, as shown in Table 5.

AST D3577 Films without Films Añejadas Añeiento Effort to Tension 24 18 Minimum (MPa) Elongation to 750 560 Minimum Break (%) Module Maximum 500% 5.5 N / A Table 5 Example 3. Method of Determination of Properties of a Guayule Latex Product In another modality, the method is a method for determination of the properties of a non-latex product synthetic, low in allergens, which is not Hevea. In this method, determine the physical or chemical properties of low allergenicity of a non-synthetic latex product processed from a natural rubber source that is not Hevea, based on the presence of proteins and other physical and chemical properties. More specifically, it is used this method to measure the natural rubber that is not Hevea processed and concentrated either by centrifugation or a combination of centrifugation and cremation. In various modalities, the method described herein is used to observe the physical properties and composition of the product latex in one or more stages in the production process, storage, transfer, or manufacturing.

Generally, the latex extracted for medical or industrial uses, including those of the present disclosure, is tested for compliance with the standard specifications of various regulatory bodies, including the values of ASTM D 1076-02. The Guayule Standard, as described herein, provides a table of standards that lists various physical and chemical properties. Each of these properties is associated with a numerical or written value to indicate the minimum or maximum standard amount allowed for a latex product to meet the requirements for that category. Written values provide a method of quantification where measurement by numerical value is difficult or impossible (for example, the words "absent" or "present" are written values.) Each property is measured according to standard methods, as required in the Guayule Standard. More specifically, the method described herein is directed to testing latex products that are not Hevea according to the protocols of the Guayule Standard, for the following physical and chemical properties, including: Total Solids Content (%) (Example 5); Dry Rubber Content (%) (Example 6); Total Alkalinity (Example 8); Viscosity; Sludge Content (Example 10); Clot Content (Example 11); KOH number (Example 12); pH; Mechanical stability (Example 14); Copper (ppm) (Example 15); Manganese (ppm) (Example 15); and Density (mg / m3).

The purity of the processing steps or the final guayule latex product is tested by determining the concentration of the protein in the aqueous phase of the latex, through the methods described below, including the analysis of the latex protein and the analysis of the antigenic protein of Hevea. The composition or global purity requirements depend on the use of the final latex product; however, generally, a reference standard for the final product includes the general conformation to the Guayule Standard for non-Hevea, for a percentage of dry rubber content higher than 40% weight concentration of latex rubber in water.

The method described herein establishes methods for testing low latex in allergens that is not Hevea in each category, as described below. In various embodiments of the method, samples may be prepared in open-top drums, closed-top drums, tank cars, or other containers, and are preferably agitated with a high-speed stirrer for about 10 minutes. In a modality, the samples can be removed from storage containers by slowly inserting a clean, dry glass tube 10-15 millimeters in internal diameter and open at both ends, until it reaches the bottom of the container and then the contents can be transferred to a dry, clean bottle. In other modalities, samples may be removed by using a metal sampling tube, a vacuum unit, a remotely operated sampling collector, or other collection method. In one embodiment, samples are collected from various parts of the container and combined prior to testing.TE.

Example 4. Presence of Proteins and Cross Reactivity of Guayule Latex Films The composition and content of proteins for guayule latex can be measured, using mouse and rabbit models, as well as in human clinical trials, using standard assay techniques, and compared with Hevea latex. In various modalities, Hev-b allergenic protein assays can be performed using ELISA (enzyme-linked immunosorbent assay), 1-D and 2-D immunostaining, skin prick tests, blood allergy test radio - Allergosorbent (RAST®), assays of the ImmunoCAP System ("CAP") (Pharmacia, alamazoo, MI), or modifications thereof, in order to detect the presence and amount of common allergenic proteins of Hev-b.

For example, as shown in FIG. 1, immunostains are prepared by using rabbit polyclonal IgG antibodies from total proteins in old rubber particles against the proteins of different latex samples, including three samples of Hevea latex and three samples of guayule latex. Reciprocal tests using mouse and rabbit antibodies show that antibodies deliberately formulated against extracted and concentrated guayule latex proteins do not cross-react with Hevea latex proteins.

In another example, the content of guayule latex proteins is compared with two samples of Hevea latex in three replicates. Total protein in the lattices is quantified by using the Modified Lowry test described in the ASTM D5712 protocols. As shown in Table 6, guayule latex contains very little protein (< 2%) in general, and compared to Hevea latex.

Table 6 Still in another example, the CAP assays (Pharmacia, Kalamazoo, MI) can be used to determine the presence and amount of Hev-b proteins in guayule latex gloves and comparer with two glove brands with Hevea latex, gloves Redline (Redline Medical Supply, Golden Valley, MN) and Triflex surgical gloves (Allegiance Healthcare / Cardinal Health, McGaw Park, IL), and synthetic gloves.

For the CAP assay, first, human sera are prepared by using accumulated human serum. Examples of human serum pools include the following: (1) Pediatric: an accumulated human anti-Hev-b IgE serum is prepared from subjects who have participated in a skin test study with Hevea C serum brasiliensis. This accumulation is combined with serum of 53 children with spina bifida with a positive clinical history for latex allergy and a positive skin test and / or IgE anti-latex serology (Hamilton et al, 1999). The two accumulated human serum accumulate to make a pediatric accumulated anti-latex IgE. (2) Adult: an accumulated human anti-Hev-b IgE serum is prepared from subjects who had participated in a skin test study with Hevea brasiliensis C serum. This pool is combined with serum from 180 adult health care workers who were known to have an allergy to Hev-b latex based on a positive history, a positive skin test, and anti-latex IgE serology. These accumulate to make the accumulated serum anti-latex IgE adult.

More specifically, in this example, when using the aforementioned accumulations, pediatric and adult serum accumulations contain 19 klU / L (allergen measurement units per liter) and 63 kIU / L, respectively, of anti-latex IgE (as shown in FIG. measured by the CAP assay.) A CAP assay is then performed to detect the inhibition of anti-Hev-j IgE in latex in three guayule latex preparations and their appropriate controls, by using control E8 Hev-b as a control reference. latex without ammonia. All extracts were tested for the detectable cross-reacting allergen Hev-b. Examples of reagents include Hev-b latex serological reagents (e.g., K82 latex CAPs, ImmunoCAP System) optimized with Hev-b proteins that are most commonly identified as allergens, as described above.

More specifically, in this modality, 0.1 ml of test guayule, synthetic, or glove material known positive for Hev-b is incubated with 0.1 ml of human serum containing anti-latex IgE. Cumulative cad of human IgE anti-latex serum is analyzed in a separate assay. Twelve dilutions of E8 latex without Hev-b ammonia are incubated with buffer solution (in duplicate) to construct a dose response curve of latex allergens from which the results of ImmunoCAP obtained with the test preparations are interpolated . After this first incubation (4 hrs at 23 ° C), each mixture is pipetted into its own latex-allergosorbent (latex K82- ImmunoCAPs Pharmacia, Kalamazoo, MI) in duplicate. The CAP assay is then completed as defined by the manufacturer with the detection of the amount of IgE bound by the addition of labeled anti-human IgE. The assay is designed so that if the Hevea latex cross-reacting material is present in some of the test preparations, it would bind to the IgE anti-Hevea latex antibody and competitively inhibit it from subsequently binding to the latex allergen. in solid phase. The differences in anti-latex IgE inhibition levels with the test preparations are compared with negative neoprene and vinyl gloves extracts. The results are then analyzed for the inhibition of IgE anti-ßfev-b latex.

By using the above human serum pools as an example, the levels of cross-reactive allergenic protein of Hev-b in the ammoniated guayule latex, two latex gloves controls, and a synthetic neoprene glove are determined by the test of ImmunoCAP inhibition, when using accumulated adult and pediatric serum, respectively. No cross-reacting allergen with Hev-b is detected in the ammoniated guayule latex preparations (which contain proteins bound to the rubber particles solubilized from the latex). Additionally, Hevea cross-reactive proteins are not detected by the CAP inhibition test in guayule ammonia latex by using either accumulated anti-adult and pediatric IgE latex serum. A basic "t" test is performed, and the degree of inhibition is not significantly different from the neoprene negative control extract (< 1 AU mi "1) .The two latex glove brands of Hevea produce 1,812 and 1,283,900 AU "1 of detectable allergen, respectively. This indicates an absence of detectable cross-reactive allergenic protein in the ammoniated guayule preparations.

In general, guayule latex does not contain any of the cross-reactive epitopes known to trigger a Hevea-type allergic response. As shown above, in FIGs. 1A and IB, guayule latex proteins do not cross-react with anti-Hevea latex protein antibodies at concentrations at least 1,000 times the amount of protein sufficient to elicit a response to Hevea proteins in allergic human patients.

The following Examples 5-15 illustrate specific examples of the manner in which the physical and chemical properties of a non-Hevea latex product are determined according to the method described.

Example 5. Method for Measuring Total Solids in a Latex Product that is not Hevea In order to determine the total solids content (TSC) of guayule latex, the following procedure can be used. In one example, approximately 2.5 ± 0.5 grams of guayule latex are weighed on a tared weight plate, covered approximately 60 mm (2.5 inches) in diameter, and 1 cm3 of distilled water is added to the latex by gently shaking the plate. The latex is distributed in the bottom of the plate in an area of approximately 32 cm2 (5 in2). The specimen is dried in an open dish in a ventilated oven with air for 16 hours at 70 ± 2 ° C or 2 hours at 100 ± 2 ° C. The cover is replaced and the sample is cooled in a desiccator at room temperature and then weighed. The drying is repeated and weighed until the mass is constant up to lmg or less. The tests are run in duplicate and verified within 0.15%. The average of the two determinations is taken as a result. The percentage of total solids is calculated as follows: Total Solids,% = [(C - A) / (B - A)] x 100, where A = weighing plate mass; B = plate mass plus the original sample; and C = plate mass plus dry sample.

Example 6. Method for Measuring Dry Rubber Content in a Non-Hevea Latex Product In order to determine the Dry Rubber Content (DRC) of guayule latex, the following procedure can be used. In one example, approximately 10 grams of guayule latex are weighed into a porcelain evaporator plate of approximately 100 mm in diameter and 50 mm deep, and aqueous acetic acid solution (20 Mg / m3) is added until the Total solids is approximately 25%. The acetic acid (2%) is then added while stirring constantly for 5 minutes, until the latex coagulates completely (up to approximately 80 cm). Up to 20 ml of hydrochloric acid (2%) can be added additionally to improve coagulation. The dish is then placed in a steam bath for 15 to 30 minutes until a clear serum results. The coagulated latex particles are then collected with the main body of the clot and washed in running water. This process is repeated until the coagulated rubber sheet reaches a maximum thickness of 2 mm.

The sheet is then dried at 70 ± 2 ° C in an atmosphere of a ventilated air oven. If oxidation occurs, the test can be run with the option of using a drying temperature of 55 ± 2 ° C, or an antioxidant can be added to the latex before coagulation. The sheet is finally cooled in a desiccator at room temperature and weighed. The drying and weighing steps are repeated until the mass is constant up to 1 mg or less. To measure the dry rubber content, multiple samples are run and verified within 0.2%. The average of the samples is taken as a result, and the dry rubber content is calculated according to the following equation: Dry rubber content,% = dry clot mass / sample mass x 100. Example 7. Method for Measuring Protein Content in a Non-Hevea Latex Product The total protein content is measured by solubilizing latex proteins in 1% SDS and 50 mM sodium phosphate buffer (final concentration) and then quantified using the modified Lowry test according to the AST Standard protocols. D5712. In the solubilization method, the latex samples (500 μ?) Are mixed with 450 μ? of 100 mM sodium phosphate buffer solution (1: 1) inside three microcentrifuge tubes for each sample; and 50 μ? of 20% SDS inside each tube, mix; and incubated at 25 ° C for 2 hours on a 200 rpm shaker. After incubation, the samples are rotated for five minutes, and the aqueous phase is transferred into the new tubes and rotated again to clarify the latex. The samples are then divided into 3 x 0.6 ml tubes for each sample (these can be stored at 4 ° C overnight). Also, the standards of bovine serum albumin (BSA) are prepared in an extraction buffer at 0, 5, 10, 15, 25, 50, 100, 200, 300, 400 pg / ml. Additionally, 60 μ? of sodium deoxycholate 1.5 mg / ml are added to the samples and standards, mixed, and allowed to stand for 10 minutes. 120 μ? of freshly mixed trichloroacetic acid at 72% and phosphotungstic acid (1: 1) is then mixed into each sample and standard, incubated for 30 minutes at room temperature, and rotated for 15 minutes to remove the supernatant. Each protein pellet is then dried in air, suspended in 250 μ? of sodium hydroxide 0.2, and stored at 4 ° C until the test. The tests are performed within 24 hours using the modified Lowry test according to ASTM D5712. Tests for the Hevea antigenic protein can also be performed by solubilizing the latex proteins with 1% SDS and 50 mM sodium phosphate buffer (final concentration) and quantified by using the antigen protein assay according to the protocols. of ASTM D6499 Standard.

Example 8. Method for measuring Total Alkalinity in a Non-Hevea Latex Product.

In one embodiment, the total alkalinity in guayule latex is measured by using a pH meter with glass electrodes and standard 0.1M HC1 (molar). The samples are first prepared by weighing 5 grams of latex into a glass weight bottle of approximately 10 cm3 capacity, having a frosted glass lid, and weighing up to the nearest 1 mg. The specimen is emptied into a beaker containing approximately 300 cm3 of distilled water, capped to prevent the loss of ammonia, and placed on one side to regress. The mass of the specimen is equal to the difference between the two weights. The samples are then transferred to a beaker with minimal loss of latex.

The electrodes of the calibrated glass electrode pH meter are inserted into the liquid to measure the pH. The pH measurements are then calibrated and made according to Test Method E 70, according to the manufacturer's instructions. While stirring, 0.1 M hydrochloric acid (HC1) is slowly added until the solution reaches a pH of 6.0. With samples of unknown alkalinity, HC1 is added in increments of 1 cm3, and pH readings are taken every 10 seconds. In another embodiment, the sample is prepared as described above, and 6 drops of alcohol solution at 0.10% methyl red are added. This solution is then titrated with approximately 0.1 molar HC1 (M) until the indicator turns pink. The end point happens before the complete coagulation takes place and the color change of the indicator against the white background of the slightly coagulated latex can be detected.

The total alkalinity can be calculated in various modalities of the method. In one embodiment, the total alkalinity is calculated in terms of NH3 based on the grams of NH3 per 100 grams of latex, as follows: Total alkalinity (as NH3)% = (1.7 x M *) / VI where: M = mol of HC1 standard; n = volume of standard HC1 required, cm3, and; = original latex mass. In another embodiment, the total alkalinity is calculated as KOH, according to the following formula: Total alkalinity (as KOH)% = (5.61 x M xn) / W where: M = mol of standard HC1, n = volume of standard HC1 required, cm3, and W = original latex mass. Still in another modality, the total alkalinity is calculated based on the water phase of the latex, using the following calculation: Total alkalinity, as% of water = (1.7 xn) / (l - TS / 100) where: TS = percentage of total solids; M = mol of the standard HC1; n = volume of standard HC1 required, cm3, and; W - original latex mass. In a further embodiment, the total alkalinity can be calculated as KOH based on the water phase of the latex, by using the following formula: Total alkalinity, (as KOH) as% water = (5.61 x M xn) / W ( 1 - TS / 100) (6) where: TS = percentage of total solids; M = mole of standard HC1; n -volume of standard HC1 required, cm3 and; W = original mass of the latex.

Example 9. Method for measuring Viscosity in a Non-Hevea Latex Product Samples for viscosity are measured using a Brookfield Viscometer, Model LVF or LVT (Brookfield Engineering, Inc., Stoughton, MA). The apparatus consists of a motor of synchronous induction type that can drive at constant rotary speeds of 0.63 and 6.3 rad / s (6 and 60 rpm) an arrow to which spindles of different shapes and dimensions can be placed, a gear train to control the speed of rotation of the spindles and a copper and beryllium spring. The spindle, when it rotates, is propelled through the copper and beryllium spring which is wound when an advance resistance is exerted on it. The amount of resistance to advance is indicated by a pointer on the face of the viscometer. This reading is proportional to the viscosity for any given speed and spindle. The Viscosimeter is calibrated by using fresh calibration oil (National Bureau of Standards) or silicone oil at ± 0.02 ° C.

To measure the viscosity, the sample is first cast through a standard 180 nm screen with apertures of 0.180 ± 0.009 mm (0.0070 ± 0.0004 inches) and wire diameter of 0.131 ± 0.01 mm (0.0052 ± 0.0005 inches) in order to adjust the latex to 60+ 0.1% total solids. The specimen is then conditioned to the desired test temperature of 25 ± 2 ° C in a water bath for a period of 2 hours in order to remove the air from the latex.

The latex specimen is then slowly emptied under the side of a beaker of 600 citi3, (cooled to 25 ° C), in order to avoid the incorporation of air. In one embodiment, the Viscometer spindle is then immersed in the sample until the surface of the latex is within the slot in the spindle shaft. Alternatively, the spindle is immersed in the latex in the previous form before placing it in the Viscometer. The Viscometer provides a reading on the scale of 100 to 0.63 and 6.3 rad / s (6 and 60 rpm) when using spindle No. 1. If the viscosity is greater than the spindle boundary No. 1, the spindle can be replaced No. 2 In order to calculate the viscosity, the reading is multiplied according to the following values, depending on the speed and the spindle used: spindle No. 1, 0.63 rad / s (6 rpm) = 10; spindle No. 1, 6.3 rad / s (60 rpm) = 1; spindle No. 2, 0.63 rad / s (6 rpm) = 50; spindle No. 2, 6.3 rad / s (60 rpm) = 5. The viscosity is then recorded in millipascales per second (mPa / s) equivalent to centipoises. Example 10. Method for Measuring Sludge Content in a Non-Hevea Latex Product.

To measure the sludge content, 45 to 50 grams of guayule latex are measured inside each of the two 50 cm3 centrifugal tubes and centrifuged for 20 minutes at approximately 240 rad / s (2,300 rpm). Each tube is secured by a lid or film to prevent evaporation of the latex or the formation of the film on the surface. Any resulting creamy formation on the surface is removed and discharged, and the latex supernatant is removed with a 2 mm pipette tip, until it remains approximately 10 mm above the top of the mud. The tubes are then filled to the top with a solution of ammonia-alcohol (comprising 28 cm 3 of ammonium hydroxide, 946 cm 3 of ethyl alcohol, 95% pure min, and 2,810 cm 3 of water) and recentrifuged by about 25 minutes, and the process is repeated until the supernatant solution is clear. After the final centrifugation, drain the tubes to the 1 cm mark and transfer the remaining residue to 200 cm3 tared beakers, using some of the ammonia-alcohol mixture as necessary. The residue is then evaporated on a hot plate, dried at 70 ± 2 ° C, and weighed. The masses of the dried residues are run in duplicate and must be adjusted within 1 mg. Example 11. Method for Measuring Clot Content in a Non-Hevea Latex Product To calculate the content of clots as a% by weight, 200 grams of a well-stirred sample of guayule latex is diluted with an equal volume of a 5% alkaline soap solution and filtered through a 180 nm mesh screen with openings of 180 ± 0.009-mm (0.0070 ± 0.000-inches) and 0.131 ± 0.01-mm diameter of the wire (0.0052 ± 0.0005-inches). After passing through a screen, the screen is washed with a 5% soap solution followed by a wash with distilled water. The sieve is then dried at 100 ± 2 ° C for 30 minutes, cooled in a desiccator, and weighed. The drying, cooling and weighing procedure is repeated at 15 minute intervals until the mass loss between the successive weighings is less than 1 mg. The difference between the original mass of the sieve and the mass of the sieve plus the clot retained in it, represents the mass of the dry clot. The percentage of clot content is calculated as follows: Clot content,% = (mi / mo) x 100 where: mo = mass of the test portion; and my = mass of clot.

Example 12. Method for measuring the number of KOH in a Non-Hevea Latex Product The KOH number is calculated by using a pH meter dependent on the electrometric measurements and a calomel assembly that flows a glass electrode to determine a pH range from 8 to 14. A sample of 50 grams of guayule latex is weighed first inside a 400 cm3 beaker, and the ammonia content is adjusted to 0.5% on the water base by the addition of 5% formaldehyde (1 cm3 = 0.0189 g of NH3) while stirring. (Formaldehyde solution (5%), cm3 = W (100 - TS) (% NH3 on the water phase - 0.50) / 189 where: W = grams of wet sample of latex g, and TS = percentage of total solids. Formaldehyde is prepared by using USP grade formaldehyde from a batch diluted to 5.0% with distilled water and neutralized with 0.1 mol of potassium hydrate (KOH) solution when using phenolphthalein as an indicator and titrant to a pale pink color).

Sufficient distilled water is added to dilute the latex to about 30% solids, and the titration electrodes are inserted into the latex sample to determine the pH. 5 cm3 of 0.5 mol KOH solution are then added while stirring, and the pH is recorded again after 10 seconds. Additions of increments of 1 cm3 of 0.5 KOH solution are added while stirring, the pH is recorded every 10 seconds after each addition, until a final point determination is made.

The determination of the end point of the titration is made at the point where the curve of the pH value forms an inflection as compared to the volume in cm3 of the KOH solution. At this point, the slope of the curve, the first differential, reaches a maximum and the second differential is zero. The final point is calculated from the second differential on the assumption that it is linear through the increase of 1 cm3 through which it passes from positive to negative. Table 7 illustrates an example of the determination of the inflection point. In Table 7, the readings are shown only in the area that approaches inflection. The points from 6.0 to 12.0 cm3 would have been taken but are not pertinent to the end point. As shown in Table 7, the slope of the line from + 0.07 to - 0.04 the intercept with zero gives a 7/11 ratio of the distance between 15.0 and 16.0 cm3 of KOH. The inflection point is, therefore, 15, 7/11, or 15.64. The tionship test can be done by the geometry of the triangles formed.

First Second Difference Difference Solution of PH ApH / Acm3? (ApH / Acm3) KOH, cm3 13.0 10.47 13.5 0.18 14.0 10.65 0.03 14.5 0.21 15.0 10.86 0.07 15.5 0.28 16.0 11.14 -0.04 16.5 0.24 17.0 11.38 -0.09 17.5 0.15 18.0 11.53 Table 7 The KOH number, expressed as the number of grams of KOH required to neutralize the acids present in 100 grams of latex solids is calculated as follows: KOH No. = (cm3 KOH x Af * 561) / (TS x mass of the sample) where: TS = percentage of total solids, and M = moles of solution standard of KOH.

Example 13. Method for Measuring the pH number in a Latex Product No Hevea The pH is calculated by using a standard meter that it depends on the electronic measurements and an assembly of calomel and glass electrode to determine the applicable pH for a pH range from 8 to 14. In one embodiment, the pH meter is calibrated according to the method E 70 and the instructions provided by the manufacturer of the meter. In this mode, the temperature range of the latex sample is adjusted to 23 ± 1 ° C by gently shaking the sample container in a bath with water at a suitable temperature. Then the pH is determined and recorded. E 1 Method to measure mechanical stability in a latex product No Hevea The mechanical stability of concentrated guayule latex is achieved by using a high speed agitation technique consisting of a stirrer, a stirring apparatus, and a test bottle. In one embodiment, the agitation apparatus is a high-speed vertical shaft agitator that can maintain a velocity of 1470 ± 22 rad / s (14,000 ± 200 rpm) during the course of the test. The shaft of the agitator is approximately 6.3 mm (0.25 in.) In diameter at its lower end at the junction point of the agitator disk and can be flared upward for greater strength, and extends to the bottom of the test bottle, while maintains a tively constant speed within 0.25 mm (0.010 inches) between the real at the specified speed.

In one embodiment, the agitation apparatus is a polished stainless steel disk 20.83 ± 0.03 m (0.820 ± 0.001 inches) in diameter and 1.57 ± 0.05 mm (0.062 ± 0.902 inches) in thickness, with a bolt threaded at its exact center for the placement at the center of the lower end of the agitator shaft. In one embodiment, the test bottle is a flat-bottomed cylindrical glass vessel, 57.8 ± 1 mm (2.28 ± 0.04 inches) in inner diameter approximately 127 mm (5 inches) in height, with a wall thickness of approximately 2.3 mm (0.09 inches). In this embodiment, the bottle can be lowered and raised to the exact position specified in tion to the arrow and the agitation apparatus.

Prior to measuring the mechanical stability, the latex is stored at room temperature and is preferably measured within 24 hours of exposure to air. In one embodiment, guayule latex is diluted to exactly 43.0 ± 0.2% total solids with an aqueous solution of ammonia (0.6% NH3) and warmed by gentle agitation at 36-37 ° C. Then the latex is cast through a 180 mm stainless steel colander with openings of 0.180 ± 0.009-mm (0.0070 ± 0.0004-inches) and wire diameters of 0.131 ± 0.013-mm (0.0052 ± 0.0005-inches). Approximately 80.0 ± 0.5 grams of the cast latex is then weighed into the test bottle and brought to a temperature of 35 ± 1 ° C.

In this mode, the latex is then agitated at 14,000 ± 200 rpm until the end point is reached, as indicated by the following conditions: latex meniscus drop, loss of turbulence, or change in sound in the shaking action . In this mode, the end point is determined by frequently submerging a glass rod into the latex and removing it once lightly on the palm of the user's hand. Small pieces of rubber coagulated in the film that are deposited in the palm signal the end of the test. This end point is confirmed by the presence of an increasing amount of rubber coagulated in a deposited film after 15 seconds of further agitation or by casting the latex through the 180 nm stainless steel screen described above. The mechanical stability value for guayule latex is expressed as the number of seconds elapsed from the start of the test to the end point. The accuracy is confirmed on multiple replica tests, where all values are within 5%.

Example 15. Method for Measuring Copper and Manganese in a Non-Hevea Latex Product The copper and manganese levels in parts per million are determined according to the methods described in ASTM D 1278 Standards.

Example 16. Method for Measuring Density in a Non-Hevea Latex Product The determinations are used to calculate the mass of a measured volume of latex in locations where it is not possible to weigh directly. For such purposes, it is essential that the density be determined in a latex sample containing the same amount of air as the latex contained when the volume was measured. Before sampling, the latex is allowed to sit for a minimum of 24 hours to ensure the dispersion of air bubbles. Two modalities of the method for calculating density are described herein, including the direct "arbitrator" method and the indirect method. In the first mode, density and volume are measured at identical temperatures (or corrected if temperatures are slightly different). In the second embodiment, the density of the latex is measured at any temperature by weighing a known amount of latex and a known quantity of distilled water in a flask of known volume. Based on this measurement and the known expansive properties of the latex, the density can be extrapolated for other temperatures (e.g., room temperature when the volume is measured).

In the "referee" direct mode, a first flask containing guayule latex is heated to a constant temperature using a water bath, and stirred. A second flask filled with distilled water is heated to a constant temperature in the same water bath. A density bottle with a capacity of 50 cm3 with a frosted glass plug pierced by a capillary and a frosted glass lid is weighed to the nearest 0.001 g and immersed up to its neck in the same water bath with the glass stopper instead, but not with the lid. All three vessels are heated to a constant temperature for approximately 20 minutes. Then the guayule latex is blown into the density bottle until it is filled, removed from the bath, and covered with the glass lid immediately. The bottle is then dried and weighed to the nearest 0.001 gram. The density bottle is recalibrated after the latex is discarded, and the process is repeated with distilled water according to the above procedure. Multiple replications can be used to ensure accuracy in the measurement.

The density of the latex is then calculated according to the following formula: D = (ML x Dw) / Mw where: D = density of the latex at the temperature of the bath at constant temperature, mg / cm 3; ML - latex mass in the bottle for density, g; Mw = mass of water in the bottle for density, g, and Dw = density of water at bath temperature, mg / m3. The density is the mass divided by the volume at a set temperature, and the units are converted where it is appropriate. The density of latex is determined in units of megagrams per cubic meter.

In the second indirect density calculation method, a volumetric flask is calibrated to weigh the nearest 1 mg. The flask is filled with distilled water at room temperature and marked with a line to indicate the water line. The flask with the water is then weighed to the nearest 1 mg. For this temperature, t, the volume of the flask is calculated up to the mark as follows: V = (Bt-A) / dt where: V = volume in cubic centimeters of the flask at laboratory temperature; t = water temperature in the flask; Bt = mass of the flask plus water at temperature t; A = mass of empty flask, and dt = density of distilled water in mg / cm3 at temperature t. Table 8 illustrates calculations of the sample at 25 ° C.

Property Measure Bt (25. OC) 156.0018g A 52.997g Body of water (25. OC) 103.004g Water density (25. OC) 0.99707 Mg / m3 V = 103.004 / 0.99707 = 103.307 V is the volume of the flask to cm3 the brand calibrated at room temperature Table 8 this modality, the density is calculated by weighing first the clean, dry flask, calibrated up to 1 mg more near. Then the guayule latex is introduced into the Flask until the flask is approximately half full, and then covered and weighed again to the nearest 1 mg. Then the plug is removed and the water is added distilled to the calibrated brand. During the addition of this water the flask is shaken to swirl periodically to release air bubbles trapped in the latex. After the level of liquid reaches the mark, the flask is covered and weighed again to the nearest 1 mg.

After mixing the contents well, the temperature is measured, and density is calculated by using the formula following: Di = (B - A) I [V- (C - B) I dt], where D, = density of the latex in mg / cm3 at temperature t; t = temperature of the latex and the mixture of water mixture in the volumetric flask; B = mass of the flask plus latex; A = mass of the empty flask; V = volume of the flask to the calibrated mark on the stem; C = mass of the flask, latex, and water to the calibrated mark on the stem, and dt = density of the distilled water of union in grams per cubic centimeter at the temperature t. Table 9 illustrates a calculation of the sample density.

Table 9 Example 17. Method for Measuring Volatile Fatty Acids in a No Hevea Volatile Latex Product The number of fatty acids, or the number of grams of potassium hydroxide (KOH) required to neutralize the volatile fatty acid in a latex sample containing 100 grams of total solids is measured using a micro-still process. In one embodiment, a Semi-Micro Alembic Markham or Semi-Micro- is used. Markham Modified Alembic (Ace Glass, Inc., Vineland, NJ), a micro burette (for example, a 10 cm micro burette) and a steam generator (for example, consisting of a 2 to 3 cm flask, a hot plate with a temperature control, and suitable connections of rubber and glass tube with carborundum crystals or a similar material to avoid knocking should be used) are used to measure the volatile fatty acids in the guayule latex.

In one embodiment, 50 ± 0.2 grams of concentrated latex are weighed into a 250 cm3 beaker and 50 cm3 of (NH4) 2S04 solution is added, while stirring with a glass rod. The beaker is immersed in a bath with water at 70 ° C for 3 to 5 minutes to coagulate the latex. The latex is then filtered to remove the serum through a dry filter paper of medium and low ash texture inside a 50 cm3 Erlenmeyer flask. The clot is squeezed into the beaker with a glass rod to remove the rest of the serum. 25 cm3 of the filtered serum is pipetted into a second 50 cm3 flask, together with 5 cm3 of H2SO4 (2 + 5), covered and shaken to mix. The still is purged by passing water vapor through it for a period of 15 minutes or more before beginning a series of tests. The inner chamber is emptied by siphon action when venting the steam generator, and then the steam supply to the still is closed and the bottom drain is opened. The discharge of water from the bottom drain creates a negative pressure to empty the interior chamber, and then the chamber is cleaned with distilled water.

To start the distillation, the water vapor supply to the still is vented, and 10 cm3 of acidified serum is pipetted, together with a drop of silicone antifoam agent, into the inner chamber. A graduated cylinder of 100 cm3 is placed under the condenser to collect the distillate and water vapor is directed through the sample in the inner chamber. The flow of water vapor is adjusted to produce the distillate at a ratio of 3 to 6 cm / min. 100 cm3 of the distillate is collected and aerated with CO2-free air. A drop of bromothymol blue indicator is added and then the sample is quickly titrated with 0.01 mole of Ba (OH) 2 solution until a blue color persists for about 10 to 20 seconds before turning green.

The number of volatile fatty acids is calculated as follows: Number of volatile fatty acids = (A x 561) / W x TS) where: A = cubic centimeters of Ba (OH) 2 solution required for the titration of the sample, M = moles of Ba (OH) 2 solution, W = latex mass corresponding to 10 cm of acidified serum, and TS = percentage of total solids in the latex. The W factor is calculated as follows: W (50 x 25) / [(50 + S) x3] where: 50 = grams of heavy latex, 25 = used cubic centimeters of serum, 50 + S = cubic centimeter of solution of ( NH4) 2S04 plus cubic centimeters of serum in 50 grams of latex, and 3 = ratio 30/10, where 30 equals 25 cm3 of filtered serum plus 5 cm of H2SO4, and 10 equals the 10 cm aliquot. The value of W depends on the total solids and the dry rubber content of the latex, but it needs to be recalculated only for important differences in these values. Table 10 illustrates various typical values of W. The volume of serum, S, is calculated as follows: S = (100-DRC) / (1.02 x 2) where: DRC = percentage of dry rubber content of the latex, and 1.02 is the specific gravity of the serum.

Table 10 Example 18. Method for Measuring Boric Acid in Non-Hevea Latex Product Reticles Containing a Boric Acid Preservative To measure the content of boric acid in the guayule latex, an amount of latex containing approximately 0.02 g of boric acid is adjusted to a pH of 7.5 in which the boric acid exists substantially in the undissociated form. Then excess mannitol is added to form the strongly acid complex of boric acid-mannitol. The hydrogen ions equivalent to boric acid present in the latex are released and the pH drops. The boric acid is determined from the amount of alkali required to restore the pH of the latex to its original value. The percentage (mass basis) of boric acid in the latex is calculated as follows: boric acid (H303) = 6.18 x MxV / M where: M = moles of the NaOH solution, V = volume of the NaOH solution required to restore the pH of the latex for 7.50 was 3, and M = mass of the latex specimen in grams.

Example 19. Method for Measuring Precision and Deviation in a Test of a Non-Hevea Latex Product The precision of each test method is estimated from a study between laboratories of three different natural rubber grids different from Hevea brasiliensis and then extrapolated for guayule latex. The guayule latex report will include deviation information and additional accuracy when available.

Example 20. Results of the Guayule Standard Test for a No Hevea Latex The tests are carried out in accordance with the procedures described in the specification values of ASTM D 1076-02 for commercially available Hevea Type 1 and Type 2 latex. Tests are also carried out according to the methods described herein for guayule latex for Total Solids Content (%); Dry Rubber Content (%); Total alkalinity, KOH as% Latex; Viscosity; Sludge content; Clot content; KOH number; pH; Mechanical stability; Copper (ppm) and Manganese (ppm); Density (Mg / m3); Protein content, Volatile Fatty Acids according to the methods described above. Tables 11 and 12 show the actual specific data for the guayule latex samples tested according to the described method. In Table 11, the sample of the tested guayule latex was processed by centrifugation and cremation. However, Table 12 illustrates experimental results for samples of guayule latex that were (1) centrifuged only and (2) centrifuged and cremated. Table 12 also shows the results for each that were (1) buffered with KOH and (2) ammoniated.

As shown in Table 11, guayule latex demonstrates results comparable to Hevea Type 1 and Type 2 latex for Total Solids Content (%); Dry Rubber Content (%); Total alkalinity, KOH as% Latex; Viscosity; Sludge content; Clot content; KOH number; pH; Mechanical stability; Copper and Manganese; Density (mg / m3) Color and Odor. As shown in Table 12, guayule latex with various ammonia compositions and buffer solution also shows results comparable to Hevea Type 1 and Type 2 latex.

Hevea Hevea Guayule Spec ASTM Spec ASTM Centrifugado y D1076-02, NL D1076-02, NRL Cremado Type 1 Type 2 Cremado (Ammoniacado) centrifugado Content of 61.3% min 66.0% min 50.0 total solids (%) Content of 59.8% min 64.0% min 48.8 Dry Rubber (%) Alkalinity 0.6% min as 0.55% min as 0.14 Total, KOH as NH3 NH3% Latex Viscosity @ 43% Without No 27.7 TSC, cps Requirement Requirements Sludges,% by weight 0.10% max 0.10% max 0.004 Clot,% at 0.05% max 0.05% max 0.002 weight KOH number 0.80 max 0.80 max ND pH Without Without 11.5 requirement requirement Stability 650 min @ 55% TSC 650 min @ 55% TSC 149 sec @ 43% Mechanical TSC Copper (ppm) 8 ppm max (rubber 8 ppm max (rubber 4.3 dw) dw) Manganese (ppm) 8 ppm max (rubber 8 ppm max (rubber 0.7 dw) dw) Magnesium (ppm) Sin No 24 requirement Density (Mg / m3) Sin Without 0.95 requirement requirement Color No blue or No blue or pronounced gray gray pronounced gray colorless Smell No odor No odor Rotten putrefying ammonia Table 11 Properties Product Product Product Product ASTM D1076-02 Latex Latex Latex Damping Cushioned Ammoniated Ammoniated with KOH of KOH of Guayule de Guayule Guayule Guayule Final Stage Centri Escape Centrifuged Spinning Centrifuged and Cremado y Cremado Processing Content of 48.0 54.0 48.0 54.0 total solids (%) Content of 47.0 53.0 47.0 53.0 Dry rubber (%) Alkalinity 0.10 0.40 0.10 0.40 Total, KOH as% Latex Viscosity @ 20.0 150.0 20.0 150.0 43% TSC, cps Sludges,% in - 0.07 - 0.07 weight Clot,% in - 0.02 - 0.02 weight pH 11.0 13.0 11.0 13.0 Stability 100.0 600.0 100.0 Mechanical 600.0 @ 43% TSC, seconds Copper (ppm) - 6.0 - 6.0 Manganese - 6.0 - 6.0 (ppm) Density 0.940 0.960 0.940 0.960 (Mg / m3) Color White White White Colorless white, colorless, discolored, discolored, beige beige beige beige Odor No odor No odor Odor Moderate odor of moderate ammonia .ammonia Table 12 Example 21. ELISA Test Results D6499 and Modified Test of Lowry D5712 for Latex No Hevea Latex gloves samples made of guayule latex are weighed and measured, and cut to allow contact of the buffer solution with all surfaces. Extraction is carried out for 2 hours with constant agitation at 25 ° +/- 5 ° C in buffered 100 mM phosphate buffered saline at a pH of 7.4 (PBS) at an extraction ratio of 5: 1 (mi of buffer / grams of sample). The latex extract is centrifuged to remove the particles and then tested using ELISA inhibition assays using the protocols of ASTM D6499, Lowry Modified Assays using the ASTM D5712 protocols, and subtraction techniques of the support when using protocols of ASTM D5712.

For the ELISA inhibition test, the sample is tested using seven series of 2 so many in series in duplicate, and then run according to the protocols of ASTM D6499. The resulting data are calculated by using latex protein extracted from non-ammoniated latex compound as a reference, and the data are expressed as antigenic protein in the latex in micrograms / gram of sample and micrograms / dm2.

For the Lowry Modified Assay, three extracts are precipitated with deoxycholate / trichloroacetic acid / phosphotungstic acid, resuspended in NaOH and then assayed using four 2-fold serial dilutions in duplicate, and the results calculated using ovalbumin as the reference standard against the resulting data, expressed in micrograms of protein / dm2, as shown in Table 13.

Table 13 Various embodiments of the invention are described above in the Detailed Description. Although these descriptions directly describe the above embodiments, it is understood that those skilled in the art can devise modifications and / or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the scope of this description are also intended to be included therein. Unless specifically noted, it is the intention of the inventors that the words or phrases in the specification and the claims be given in the ordinary and customary meanings for those with ordinary experience in the applicable techniques.

The above description of a preferred embodiment and a best mode of the invention known to the applicant at the time of the presentation of the application has been presented and is intended for the purposes of illustration and description. It is not intended to be exhaustive, not to limit the invention to the precise form described, and many modifications and variations are possible in light of the above teachings. The modality was chosen and described in order to better explain the principles of the invention and its practical application and enable other experts in the art to better utilize the invention in various modalities and with various modifications as is suitable for the particular use contemplated. Therefore, it is intended that the invention is not limited to the particular embodiments described for carrying out the invention.

Claims (28)

NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and therefore the content of the following is claimed as property: CLAIMS

1. A latex product, characterized in that it comprises: elastomeric material comprising rubber derived from a non-Hevea plant, the elastomeric material having characteristics that include a non-detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and substantial impermeability to water vapor and liquid water.

2. The latex product according to claim 1, characterized in that the plant that is not Hevea is guayule.

3. The latex product according to claim 1, characterized in that the Hevea antigenic protein is selected from a group consisting of: Hev bl, Hev b3, Hev b2, Hev b4, Hev b6.01, Hev b6.02, Hev b6.03, Hev bl.Ol, Hev bl.02, Hev bll, Hev bl2, Hev b5, Hev b8, Hev b9, and Hev blO.

. The latex product according to claim 1, characterized in that it further includes having the characteristic of no detectable amount of some Hevea antigenic protein when measured according to ASTM D6499.

5. The latex product according to claim 4, characterized in that the antigenic proteins of Hevea include Hev bl, Hev b3, Hev b2, Hev b4, Hev b6.01, Hev b6.02, Hev b6.03, Hev bl.Ol , Hev bl.02, Hev bll, Hev bl2, Hev b5, Hev b8, Hev b9, and Hev blO.

6. The latex product according to claim 1, the elastomeric material characterized in that it further includes having the characteristic of a total alkalinity equal to or greater than about one tenth of one percent.

7. The latex product according to claim 1, the elastomeric material characterized in that it further includes having the characteristic of no detectable odor.

8. The latex product according to claim 1, characterized in that it further includes having the characteristic of a ratio of hydrophobic protein to hydrophilic protein equal to or greater than about nine to one.

9. The latex product according to claim 1, characterized in that it also includes at least one layer of the elastomeric material.

10. The latex product according to claim 9, characterized in that the layer of elastomeric material comprises a coating for a second latex product, wherein the second latex product is selected from a group consisting of: a Hevea latex product and a synthetic latex product.

11. The latex product according to claim 10, characterized in that the latex product that is not Hevea, which is not guayule, is derived from a rubber producing species, selected from the group consisting of: tartago, mariola, rabbitbrush or rabbit tail, milkweeds, goldenrods, pale banana tree from India, Russian dandelion, mountain mint, American kelp, Madagascar rubber vine and tall campanula.

12. The latex product according to claim 9, the layer of elastomeric material characterized in that it further includes having a configuration that includes four receptacles for the fingers; a receptacle for the thumb, and that can cover a human hand.

13. The latex product according to claim 1, characterized in that the elastomeric material forms a portion of a medical device.

14. The latex product according to claim 13, characterized in that the medical device is selected from a group consisting of: a glove, a catheter, a medical adhesive, a wound care product, a laboratory test kit, a test, a disposable kit, a drug container, a syringe, a valve, a seal, a port, a plunger, forceps, a dropper, a cap, a bandage, a wound dressing, a test sheet, a cover for endo-devices, a bag for solution, a balloon, a thermometer, a spatula, flexible tubing, a bonding agent, a needle cover, a tourniquet, tape, a mask, a stethoscope, a compression band, ties, a inflation system, a truss, a splint, a cervical neck, and crutches.

15. A method for identifying a latex product with low allergenicity, characterized in that it comprises: obtaining a sample of the latex product for identification; detecting the presence or absence of a Hevea antigenic protein in the sample according to ASTM D6499; measure the total protein content in the sample according to ASTM D5712; Y determine that the sample has low allergenicity when no Hevea antigenic protein is detected and the total protein represents less than or equal to approximately two hundred micrograms per gram of latex in dry weight.

16. The method according to claim 15, characterized in that the Hevea antigenic protein is selected from a group consisting of: Hev bl, Hev b3, Hev b2, Hev b4, Hev b6.01, Hev b6.02, Hev b6. 03, Hev bl.Ol, Hev bl.02r Hev bll, Hev bl2, Hev b5, Hev b8, Hev b9, and Hev blO.

17. The method according to claim 15, characterized in that it further includes detecting the presence or absence of a set of Hevea antigenic proteins when measured according to ASTM D6499.

18. The method according to claim 17, characterized in that the set of Hevea antigenic proteins includes two or more Hevea antigenic proteins selected from the group consisting of: Hev bl, Hev b3, Hev b2, Hev b4, Hev b6.01, Hev b6.02, Hev b6.03, Hev bl.Ol, Hev bl.02, Hev bll, Hev bl2, Hev b5, Hev b8, Hev b9, and Hev blO.

19. The method according to claim 15, characterized in that it further includes measuring a ratio of hydrophobic protein to hydrophilic protein of the sample; and determining that the sample has low allergenicity when the ratio of hydrophobic protein to hydrophilic protein is equal to or greater than about nine to one.

20. The method according to claim 15, characterized in that it also includes determining the total alkalinity of the sample; and determining that the sample has low allergenicity when the total alkalinity is greater than or equal to about one-tenth of one percent.

21. The method according to claim 15, characterized in that it also includes detecting the presence or absence of odor emanating from the sample; determine that the sample has low allergenicity when there is no detectable odor emanating from the sample.

22. A latex product, characterized in that it comprises: a dry film comprising rubber derived from a guayule plant, the dry film having the characteristics including no detectable amount of a Hevea antigenic protein when measured according to ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and substantial impermeability to water vapor and liquid water.

23. A glove, characterized in that it comprises: elastomeric material having a configuration that includes four receptacles for the fingers, a receptacle for the thumb, and which can cover a human hand; and wherein the elastomeric material comprises rubber derived from a guayule plant, the elastomeric material having characteristics that include no detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and impermeability to pathogenic human viruses.

24. A catheter, characterized in that it comprises: elastomeric material comprising rubber derived from a guayule plant, the elastomeric material having characteristics that include no detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and substantial impermeability to water vapor and liquid water.

25. A device capable of preventing the sperm of a mammal from fertilizing an ovule of a mammal, characterized in that it comprises: a barrier comprising elastomeric material, the elastomeric material comprising rubber derived from a guayule plant, the elastomeric material having characteristics that include no detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and the impermeability to the sperm of a mammal.

26. The device according to claim 25, characterized in that the barrier is selected from the group consisting of: a male condom, a female condom, a sponge, a cervical cap, and a diaphragm.

27. A dental dam, characterized in that it comprises: elastomeric material comprising rubber derived from a guayule plant, the elastomeric material having characteristics that include no detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and substantial impermeability to water vapor and liquid water.

28. A condom, characterized in that it comprises: a body having a wall, a closed end and an open end, the wall defining a prominence including an inner surface and an outer surface, wherein the body comprises an elastomeric material comprising derived rubber of a guayule plant, the elastomeric material having characteristics that include no detectable amount of Hevea antigenic protein when measured in accordance with ASTM D6499; a total protein content of less than or equal to about two hundred micrograms per gram of latex by dry weight when measured in accordance with ASTM D5712; and impermeability to pathogenic human viruses.