About Eastman Tritan™ copolyester product safety
Eastman Tritan™ copolyester is known for its toughness — and ability to stand up to the day-in/day-out torture test that comes with everyday consumer use. But no one is tougher on Tritan than Eastman's researchers and engineers.
Eastman Tritan™ copolyester has been developed using industry-recognized testing for attributes such as toughness, clarity and sustainability. In addition, Tritan has passed numerous tough safety tests.
Eastman Tritan™ copolyester testing
Independent third-party laboratories used several well-recognized scientific methods to test Eastman Tritan™ copolyester for potential estrogenic or 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.
- Receptor transactivation assays.2, 3 The estrogenic 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 (FDA) and European (specifically, Commission Regulation (EU) No. 10/2011) recommendations for food contact migration testing. Additional extracts were derived following a dishwasher simulation environment (10 days, 70ºC in Cascade® solution).
- 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.
- Uterotrophic assay. This is considered a definitive test for assessing a chemical's potential to elicit estrogenic or androgenic responses in living biological systems. This in vivo test is part of the Tier I Endocrine Disruption Screening Program of the U.S. Environmental Protection Agency.
- Hershberger assay.4 This is considered a definitive test for assessing a chemical's potential to elicit estrogenic or androgenic responses in living biological systems. This in vivo test is 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 Eastman Tritan™ copolyester is free of estrogenic and androgenic activity.
- In addition, a peer-reviewed article, authored by third parties, about the lack of AA and EA of the three monomers used in Tritan was recently published in Food and Chemical Toxicology, Vol. 50, Iss. 6. This article is a summary and analysis of all the research and testing completed to date on the monomers used in Tritan. The research concluded that Tritan does not exhibit AA or EA and reaffirms the safety of Tritan.
1 Conducted by Dr. William Welsh, Department of Pharmacology, University of Medicine and Denistry of New Jersey-Robert Wood Johnson Medical School, Piscataway
2 Conducted by CeeTox Inc, Kalamazoo, Mich.
3 Conducted by the Center for Environmental Biotechnology, University of Tennessee, Knoxville
4 Conducted by WIL Research Laboratories, LLC, Ashland, Ohio
Eastman Tritan™ copolyester regulatory and standard approval
The methods used to test Eastman Tritan™ copolyester, as well as the test results and material itself, have been reviewed independently and approved by numerous regulatory and standard agencies, including:
- Health Canada, which has allowed the use of Tritan in food contact applications.
- U.S. Food and Drug Administration, which provided clearance for use in food contact applications.
- European Food Safety Authority, which provided clearance for use in food contact applications; and the European Commission, the executive arm of the European Union (EU), which approved the Plastics Implementing Measure allowing the use of a key Tritan monomer for repeat-use food contact applications.
- Japan Hygienic Olefin and Styrene Plastics Association, which amended its list of certified polymers to include the composition of Tritan.
- China's Ministry of Health, which released an initial list of certified safe food contact packaging materials that includes Tritan.
- NSF International, which approved Tritan for food equipment materials (NSF 51) and drinking water system components (NSF 61).
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