The following FAQs and their answers provide much of the commonly sought out information regarding natural rubber latex in general and Vytex® Natural Rubber Latex (NRL) specifically. If you do not see your question or feel that you would like a more in-depth answer, please contact us.
What is Natural Rubber Latex (NRL)?
NRL is the protective fluid contained in tissue beneath the bark of the rubber tree, Hevea brasiliensis. It is a cloudy, white liquid collected by cutting a thin strip of bark from the tree and allowing the latex to be secreted into a collection cup over a period of several hours. It consists of approximately 30-40 percent rubber particles, 55-65 percent water and small amounts of protein and other substances.
Where is Natural Rubber Latex produced?
Today, more than 90 percent of the NRL supply comes from Southeast Asia locations such as Thailand, Malaysia and India. Rubber trees require a hot, damp climate, and grow only in the “Rubber Belt” — an equatorial zone that stretches around the world. In 1876, the English, in recognition of the difficulties of securing quality rubber from the jungle, hit upon the idea of growing rubber on plantations. From their efforts, the cultivated rubber tree plantations of Southeast Asia and parts of Africa have developed.
What makes Vytex® unique?
Vytex is a natural rubber product that has been modified using green chemistry to significantly reduce protein content without compromising the physical properties of products made with this raw material. Vytex can be used as a standard source material for many product applications and wherever Hevea natural rubber or synthetics are used.
Where is Vytex® produced?
Vytex is produced at the natural rubber processor level and can be easily integrated without the capital need for special or additional equipment.
What are latex allergies? Who is at risk?
Latex allergy is an allergic reaction to certain proteins in natural rubber latex. There are three known types of latex reactions;
- Irritant contact dermatitis
- Allergic contact dermatitis
- Immediate allergic reaction, that includes anaphylaxis (latex hypersensitivity)
It is estimated that up to 17% of American healthcare workers and up to 73% or more of frequently exposed patients, such as those with spina bifida, have become sensitized to the antigenic latex proteins. Approximately 3% of the general population is at risk for a latex reaction.
What is the accepted method for Natural Rubber Latex protein testing?
Currently, there are 2 different test methods that are considered industry standards to test the proteins in natural rubber latex: (1) Modified Lowry and (2) ELISA. The test that has been around the longest is the Modified Lowry. This method, referred to as ASTM D 5712-05, was approved in April 1995 and updated in 2005. The test measures the total water extractable protein on a latex product including, but not limited to, any milk protein (used by some manufacturers), enzymes, natural rubber latex proteins and any other types of protein present.
The second most frequently used test is the ELISA test. The ELISA test is referred to as the ASTM D 6499-07 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products ELISA Inhibition Assay uses an Inhibition ELISA to quantify antigenic latex protein in product extracts. In the ELISA, soluble antigens in the extract compete for binding to specific anti-latex antibodies and block antibody binding to latex antigen immobilized on the surface of the assay plate. Results are usually expressed in micrograms of antigenic protein per gram (ug/g) or square decimeter (ug/dm2) (a measurement of surface area).
Is there a particular protein level that can cause an allergic reaction?
As with most allergies, researchers have not been able to determine the exact level of natural rubber latex protein exposure, or how many exposures, will cause an individual to become allergic or to begin expressing symptoms. There is scientific consensus that reduced antigenic protein levels will lower the potential for both sensitization of non-sensitized genetically susceptible individuals and allergic reactions in sensitized individuals.
Why is a reduced level of total protein important?
Scientific studies provide evidence that the greater the overall exposure to an allergy-causing substance, the greater the risk of sensitization in genetically predisposed individuals. Reduced exposure to natural rubber latex allergenic proteins has been reported in the literature to be associated with decreased allergenic response.
Can I compare the test results for the Modified Lowry and ELISA Inhibition Assay tests?
No. The ELISA Inhibition assay is a method used to test for antigenic latex proteins. The Modified Lowry assay is a method used to test for total water-extractable protein. Because each test method determines a different substance (total vs. antigenic protein) and employs different procedures, the end results cannot and should not be compared.
What are the protein differences between Vytex® NRL and Hevea natural rubber latex?
Overall, Vytex NRL typically has 90% fewer antigenic proteins than Hevea natural rubber latex.
What products can Vytex® NRL be used in place of Hevea natural rubber latex?
Vytex NRL has been designed as a standard source material that can be used in place of Hevea natural rubber latex in virtually any application. There are more than 40,000 commercially available products made from Hevea natural rubber latex. These products include medical goods such as surgical and exam gloves, breather bags, probe covers, tubing; consumer products like condoms and balloons; and commercial products such as cold seal and pressure sensitive adhesives and foam mattresses and pillows. Vytex NRL has been successfully trialed in many of these product applications potentially offering end-users the performance they expect from NRL with significantly reduced antigenic protein values.
Are any changes necessary to my manufacturing processes to use Vytex® NRL?
No. The production of Vytex NRL removes proteins and other unwanted impurities from the liquid latex but does not change its performance in the manufacturing environment. However, since a significant amount of proteins are removed during Vytex NRL processing, manufacturers seeking to reduce protein leaching times may now have an opportunity to do so with the use of low protein Vytex NRL.
Are storage requirements different for Vytex® NRL?
No. However since Vytex NRL has been specially processed to remove proteins and other unwanted impurities, we recommend that existing storage tanks be thoroughly cleaned prior to storage and use of Vytex NRL.
Can I use the same Hevea natural rubber latex compounding chemicals with Vytex® NRL?
Vytex NRL has the same or improved properties to untreated Hevea natural rubber latex and should be compatible with current compound formulas. The Vystar technical team is available to assist manufacturers with the integration of Vytex NRL within their current manufacturing processes.
Can leaching time be reduced for products made from Vytex® NRL?
Since Vytex NRL starts with ultra low protein levels in liquid latex, it can be hypothesized that extensive post leaching times for protein reduction can be minimized. Since every manufacturer’s production process is unique, please consult with the Vystar technical team for your particular application.
What are the end physical performance differences between Vytex® NRL and Hevea natural rubber latex?
The physical properties of products made from Vytex NRL under similar conditions and processes used for Hevea natural rubber latex are within the standard industry specifications for natural rubber products Type 1 classification. Vytex NRL typically exhibits a lower initial modulus and good resistance to aging compared to products made from Hevea natural rubber latex.
How do products made from Vytex® NRL behave upon aging?
Vytex NRL is ‘passivated’ during treatment, which reduces its sensitivity to UV and IR frequencies. It maintains its strength during artificial heat aging, which enhances the barrier protection properties over Hevea natural rubber latex. Our test results indicated condoms made with Vytex NRL were 30% stronger than condoms made from Hevea natural rubber latex when aged for 100°C for 22 hours and exam gloves made with Vytex NRL aged under similar conditions had a 32% lower initial modulus compared Hevea NRL. The Vytex process removes and deactivates those molecular species vulnerable to free radical breakdown.
There has been a lot of news recently about phthalates. What are phthalates and are they in Vytex® NRL?
Phthalates, or phthalate esters, are a group of chemical compounds that are mainly used as plasticizers (substances added to plastics to increase their flexibility). They are primarily used to turn vinyl from a hard plastic into a flexible plastic. They are a known human carcinogen. Vytex NRL does not contain any phthalates.
I am a manufacturer and I would like more information on how my product could use Vytex NRL?
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Vystar Corporation
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Duluth, GA 30096
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