POLYOX™

SDSs issued in Europe are in compliance with all applicable European legislation requirements, including REACH requirements as interpreted by the European Commission. 

Due to practical challenges of implementing the SDS changes required by REACH before the start of the Registration process, the European Commission supported the CEFIC position with respect to the following key points:

• The only requirements that could reasonably be implemented by June 1, 2007 were mainly format changes. (These include reversing the content of Sections 2 and 3, inserting the e-mail address of the individual responsible for creating the SDS in Section 1, and for substances not classified as dangerous, adding the reason for indicating the substance in Section 3).
• SDSs that do not need to be revised for reasons other than the above format changes can stay in the pre-REACH format and are considered to be still in compliance because their content is correct. For newly created SDSs, and for revised SDSs, the format changes must be implemented.
• All changes required by REACH as described in articles 31 and Annex II of the Regulation should be implemented before Dec 1, 2010, which coincides with the first deadline for registration. Until that date, the SDSs circulating in Europe will be in 2 different formats.

The manufacturer has implemented the above recommendations of the European Commission. On this basis, our SDSs comply with the REACH requirements as currently defined and interpreted by the European Commission. 

The manufacturing facilities in Germany (Stade, Bomlitz, and Bitterfeld-Wolfen) are certified for Environmental Management for ISO 14001.

See attachments below.

FileAttachments
004486 QM15_UM15 2017-09-22 englisch Germany Exp 2020-09-21.pdf (741.33 KB)

High Binding Efficiency -- POLYOX Water-Soluble Resins have high-binding efficiency for pigments, fillers, metal powders and ceramics. These binders easily burn off at low temperatures with little or no tendency to char.

Form Novel Complexes -- The strong hydrogen bonding affinity of POLYOX Water­-Soluble Resins accounts for the association of these polyethers with various polar compounds, such as phenolic resins, mineral acids, halogens, ureas, lignin sulfonic acids and poly (carboxylic acids). These novel complexes can be discrete chemical entities resulting from very strong intermolecular association and often exhibit properties markedly different from either component.

Crosslinkable -- POLYOX Water-Soluble Resins can be crosslinked to form gels that are highly water-retentive.

Emollient -- When applied to the skin and hair, POLYOX Water-Soluble Resins produce a soft and “silky” feel.

Film Former, Excipient -- POLYOX Water-Soluble Resins can be formed into flexible films both by thermoplastic processing and casting techniques. Such films may be made of POLYOX™ Water-Soluble Resins alone or blended with a wide variety of other polymers, such as polyethylene, polystyrene, polycaprolactone, ethylene vinyl acetate, nylon, etc.

Low Toxicity -- POLYOX Water-Soluble Resins show a very low order of toxicity in animal studies by all routes of exposure. At the maximum practical oral dose to rates of about 2 g/kg of body weight there were no deaths nor signs of toxicity. Because of their high molecular weights, the resins are poorly absorbed from the gastrointestinal tract and are completely and rapidly eliminated. These resins are neither skin irritants nor sensitizers, nor do they cause eye irritation as the dry powder or as aqueous solutions.

Flocculant Activity -- High molecular weight grades of POLYOX Water-Soluble Resins effectively adsorb onto many colloidal materials and perform as efficient flocculating agents. They exhibit a high affinity for a variety of materials, including silica, clays, oxidized coal fines, lignins and paper fines.

Lubricity -- POLYOX Water-Soluble Resins impart a high degree of lubricity when in contact with water.

Solubility/Thickening of Many Organic Solvents -- POLYOX Water-Soluble Resins are readily soluble in and will thicken a wide variety of organic solvents at various temperatures. Typical organic solvents include most haloge­nated hydrocarbons, various ketones, alcohols, aromatic hydrocarbons and esters. POLYOX Water-Soluble Resins are not generally soluble in aliphatic hydrocarbon solvents, glycols, diols and aliphatic ethers.

Thermoplasticity -- As thermoplastics, POLYOX™ Water-Soluble Resins are readily calendered, extruded, injection molded, or cast. Sheets and films of this material are heat-sealable and can be oriented to develop high strength. Films are inherently flexible, tough and resistant to most oils and greases. These resins are compatible with many natural and synthetic polymers. The combination of thermoplasticity and aqueous solubility and compatibility with “hydrophobic” polymers (e.g., polyethylene, polycaprolactone, ethylene vinyl acetate, nylon, etc.) make POLYOX Water-Soluble Resins a valuable asset for degradable plastics applications.

Wet Tack -- POLYOX Water-Soluble Resins exhibit a high degree of wet tack and, thus, are useful as wet adhesives. The dried residue is non-tacky.

Thickening Power (Aqueous) -- POLYOX Water-Soluble Resins are nonionic and completely water-soluble at all tempera­tures up to the boiling point of water. Unlike most other high molecular weight, water-soluble resins, they do not exhibit an inverse solubility-temperature relationship, except near the boiling point.

POLYOX Water-Soluble Resins are extremely effective thick­ening agents in both fresh and salt water. Aqueous solutions are pseudoplastic (i.e., shear thinning).

Drag Reduction/Drift Control -- Very low concentrations of the higher molecular weight POLYOX Water-Soluble Resins can reduce the turbulent frictional drag of the water in which they are dissolved by as much as 80 percent.

Viscoelasticity -- The flexibility of ether linkages combined with the extremely high molecular weight of POLYOX™ Water-Soluble Resins produces solutions with elastic behavior. Such solutions will climb a rotating shaft! This property also tends to reduce both the spattering and misting potential of aqueous solutions.

Available in Many Grades -- POLYOX Water-Soluble Resins are supplied in a wide variety of molecular weight grades and formulated compounds in standard and NF (National Formulary) grades.

POLYOX Water-Soluble Resins are produced and supplied as white, granular powders, freely soluble in water and possessing a slightly ammoniacal odor. Typical properties are given in table below.

Typical Physical Properties⁽¹⁾ of POLYOX Water-Soluble Resins

All POLYOX Water-Soluble Resins are sold containing some level of BHT (butylated hydroxytoluene) antioxidant.  You may add additional BHT as needed.  The pharmaceutical grades of POLYOX resin contain 100 - 1000 ppm (industrial grades contain 0.1% max) BHT with the exact level depending on the molecular weight of the polymer. Information regarding the presence and level of BHT in the product can be found on the label of the product.

Vitamin E is also used in pharmaceutical applications as an oxidative stabilizer.   The typical use level is 500 - 1000 ppm.   To achieve good mixing of vitamin E into the POLYOX powder, one can dissolve the vitamin E in a small amount of isopropyl alcohol before mixing it with the POLYOX powder.

In solution, the use of alcohols or glycols (isopropyl alcohol, propylene glycol, and glycerol) at approximately 5 - 10% wt has the benefit of reducing loss of solution viscosity on aging since these solvents behave as solution viscosity stabilizers. 

In industrial applications, a solid stabilizer that can be added to the powder or to solution is 0.1 wt% sodium thiosulfate.  Sodium thiosulfate acts as a chlorine scavenger and is most useful for processes using municipal (treated) water.

The maximum amount of free ethylene oxide (EO) is as listed on the SENTRY grade (pharmaceutical grade) sales specification.  For the SENTRY pharmaceutical grades the maximum amount of free EO is 0.001% or 10 ppm.  We do offer low EO (LEO) grades, primarily for pharmaceutical use in Europe.  For the SENTRY LEO grades the maximum amount of free EO is 0.0001% or 1 ppm.  Over time and storage conditions the EO content will only decrease.

POLYOX Water-Soluble Resins are supplied in a wide variety of molecular weight grades and formulated compounds in standard and NF (National Formulary) grades. The table below shows the current product range and their corresponding molecular weights and properties. See the link below for a summary of the solution properties of each type.  Both thickening efficiency and pituity (i.e., viscoelastic behavior) increase with increasing molecular weight.

POLYOX Water-Soluble Resins are produced and supplied as white, granular powders, freely soluble in water and possessing a slightly ammoniacal odor.






¹Based on rheological measurements.  Molecular weights obtained by other methods, including light scattering and gel permeation chromatography, may not be directly comparable.

²Model RVT

³POLYOX Water-Soluble Resins-NF comply with The National Formulary standard for "Polyethylene Oxide" in the current USP/NF.
 

POLYOX Water Soluble Resins are a class of polymers called polyethers, and as such, can undergo chain cleavage via auto-oxidation. Therefore, these products will degrade to lower molecular weight hence lower solution viscosity. Variables such as time, elevated temperature, and exposure to oxygen can impact the rate at which these polymers degrade. The rate of degradation is also dependant on the grade. Higher molecular weight grades are more sensitive than the lower molecular weight grades.

The rate of auto-oxidation can be minimized through the addition of antioxidants and by controlling storage conditions. POLYOX Water Soluble Resin grades are supplied with atypical range of butylated hydroxytoluene (BHT) content from 50 to 1000 ppm. BHT is a safe and effective antioxidant for polyethers.

The manufacturer supplies SENTRY POLYOX Water Soluble Resins based on analytical testing to ensure that material is within the viscosity specification. In some cases, extra measures are taken to ensure that product can withstand shipping times and still reach customers well within specification. One measure includes conducting retesting of batches of material to ensure viscosity specification compliance.  Improvements have been made to the retest interval of several of our SENTRY POLYOX Water Soluble Resins NF grades.  The retest interval for all of our mid molecular weight grades in 140-lb drums is being expanded from 6-months to 12-months.

This change went into effect on July 1, 2016.  The SENTRY POLYOX product families are shown below, which include both LEO and non-LEO, FP, and SFP grades:

 

This change represents a significant response to our most frequently received customer request: longer retest intervals.  A multi-year internal study was initiated which resulted in a better understanding of product stability and our ability to extend retest intervals through the use of tighter manufacturing controls.  The results of this study support an expansion of the retest intervals for the grades where indicated above.

The material may be used beyond the retest date if appropriate testing and examination shows it is still suitable for use. All other parameters are stable and do not require reevaluation.

The manufacturer does not list the last retest date on certificates of analysis for Standard grades of SENTRY™ POLYOX™ Water Soluble Resins. The result on the certificate analysis does reflect the results from the last testing conducted. With this in mind, it is important not to conclude that material is out of specification or near the end of its shelf-life based on its date of manufacture. As indicated, material is often retested and as such re-qualified following our testing procedures.

Storage and Handling Technical Data Sheet  (36KB PDF)

Dust Explosibility Technical Data Sheet  (38KB PDF)

FileAttachments
SENTRY POLYOX WSR Technical Information on Stability.pdf (636.60 KB)
POLYOX_Shelf_Life_Storage_Handling_Public_Aug2016.pdf (158.88 KB)