What is a polymer? The term "polymer" is often used to describe plastics and other materials. Literally translated, polymer means "many units." These units are sometimes referred to as monomers, and they are the building blocks that form a plastic. To form a plastic article, these monomers undergo a chemical change that causes them to become connected to each other.
How do I know if a plastic (or polymer) is safe? Your best way to identify safe plastics is to know how thoroughly they have been tested -- and how reliable are the scientific testing and conclusions. Evaluating a plastic using a comprehensive set of reliable and definitive tests is the best approach.
For your safety, a plastic resin like Tritan must undergo a variety of tests before the U.S. Food and Drug Administration will allow the plastic to be used in products that can come in contact with food or drink. Tritan has been thoroughly tested by independent third-party laboratores using well-recognized scientific methods, and has been cleared by worldwide regulatory agencies for use in products that contact food.
What is BPA? Bisphenol A (BPA) is a monomer used in some plastics, including polycarbonate. BPA also is used in the interior coatings of metal cans that hold food to prevent deterioration of the metal surface.
Besides BPA, are there any other bisphenol analogs (such as BPS) used in the manufacture of Tritan? Tritan is not manufactured with BPS or any other bisphenol compound that would be chemical analogs of BPA. there is no reason to expect that these substances would be present in the material.
Is Tritan made with BPA? BPA is not and has never been an ingredient or byproduct of the production of Tritan. Validation that the material is BPA-free plastic is supported by extensive testing, using well-recognized scientific methods.
What is estrogenic activity? Androgenic activity? Estrogen and testosterone are hormones that are essential to many important biological processes in animals and humans, including sexual differentiation and development. Studies have suggested that certain synthetic and naturally occurring chemicals can interfere with these biological processes and lead to adverse effects.
Endocrine disruptors are defined as chemicals that can interfere with the human endocrine system and ultimately lead to adverse health effects. Among endocrine disruptors, chemicals that mimic estrogen and testosterone in living animals are said to exhibit estrogenic activity, also known as EA, and androgenic activity, frequently known as AA.
Independent third-party labs using well-recognized scientific methods have demonstrated that Tritan plastic is free of estrogenic activity and androgenic activity.
If a product is stamped with a “7,” does it mean that it contains BPA? No; nor is it a measure of the safety of a product. The number, usually located in the center of the triangular recycle symbol, is called the “resin identification code” and is intended to facilitate sorting of materials for recycling. Currently, resin identification code “7” is for “other” resins that are not defined by codes 1 through 6. Thus, a number of unrelated plastics can carry a code 7, including Tritan, polycarbonate, nylon and even the newer bio-plastics. Many well-known manufacturers identify their products made from Tritan with code 7.
What are the details of the Eastman lawsuit regarding EA? The purpose of the Eastman lawsuit was to prevent PlastiPure, Inc., and its sister company CertiChem, Inc., from making false and misleading statements about Tritan in commercial materials, attempting to benefit their businesses. during the jury trial, neither the principals or scientists within PlastiPure and CertiChem nor their testifying experts would say under oath that they believed Tritan was harmful to humans.
The jury found that statements made by PlastiPure and CertiChem that Tritan had estrogenic activity or that Tritan was dangerous because it exhibited estrogenic activity were false and misleading, resulting in the court issuing an injunction prohibiting CertiChem and PlastiPure from making such statements in any
commercial manner.
On July 24, 2013, a federal jury in Austin, Texas, ruled in favor of Eastman against PlastiPure and CertiChem. Through evidence presented during the Eastman lawsuit, the company demonstrated that false and misleading statements were made against Tritan, and the safety of the material was upheld.
What methods were used to test Tritan?
Accredited universities and independent third-party labs used well-recognized scientific methods to test the plastic resin for potential estrogenic activity and androgenic activity. This battery of tests included: -
Quantitative structure activity relationships (QSAR).1 Computer modeling of monomers to assess each substance's molecular structure and its ability to bind to human estrogen and androgen (testosterone) receptors in a manner that could lead to their activation.
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Receptor transactivation assays.2,3 The estrogenic activity and androgenic activity of both the monomers and concentrated extracts of Tritan also were evaluated in vitro using both yeast and mammalian cell assays performed by two separate labs. These tests evaluate a substance's ability to bind to a hormone receptor and, induce gene expression. Extracts were generated using U.S. Food and Drug administration and European Union (EU) (specifically, Commission Regulation No. 10/2011) recommendations for food contact migration testing. Additional extracts were derived following a dishwasher simulation environment (10 days, 70ºC in Cascade® solution).
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Competitive binding assays.2 Despite the fact that neither the QSAR nor transactivation studies showed any evidence of binding or gene expression by estrogenic or androgenic pathways, a second tier of tests based on competitive binding assays was conducted. These tests can confirm a substance's ability to specifically bind to a specific hormone receptor and can be used to calculate the relative binding affinity.
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Uterotrophic assay.4 This
in vivo test is considered more definitive for assessing a substance's potential to elicit estrogenic responses in living biological systems. This test is also part of the Tier I Endocrine Disruption Screening Program of the U.S. Environmental Protection Agency.
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Hershberger assay.5 This
in vivo test is considered more definitive for assessing a substance's potential to elicit androgenic responses in living biological systems. This test is also part of the Tier I Endocrine Disruption Screening Program of the U.S. Environmental Protection Agency.
The uniformly negative responses seen in these complementary third-party studies overwhelmingly demonstrate that Tritan is free of estrogenic activity and androgenic activity.
1 Conducted by Dr. William Welsh, Department of Pharmacology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway 2 Conducted by CeeTox Inc., Kalamazoo, Michigan 3 Conducted by the Center for Environmental Biotechnology, University of Tennessee, Knoxville 4 Conducted by WIL Research Laboratories, LLC, Ashland, Ohio
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