Biocompatibility Testing

Giant Steps

Eastman Tritan™ EX401 copolyester addresses health and regulatory issues important to the infant care market. With this resin, Eastman takes the first steps toward assessing the effects of products in contact with the body. Eastman is using the introduction of Tritan EX401 to lead the industry toward establishing biocompatibility testing protocols for the infant care market.

Eastman Tritan™ EX401 copolyester is included in Eastman Chemical Company’s Customer Notification Procedure which details our policy for customer notification when significant changes are made in Tritan EX401 sold into the infant care market. This procedure provides the infant care industry an added layer of confidence in the consistent quality and performance of Tritan.

You take health seriously

Consumers are concerned about the safety of anything contacting their food, and the marketplace has spoken loudly regarding consumer products containing BPA. The infant care industry continues to work to eliminate BPA from products, including bottles, pacifiers, and breast pumps, used worldwide by children three years old or less. Some countries and geographic regions have pending legislation to eliminate BPA from all food contact applications regardless of the age of the user.

Demonstrating safety should be a priority in the infant care market. When developing Eastman Tritan™ EX401 copolyester, the company sought standardized testing protocols that would inspire customer confidence in products that contact the body. Because no established testing protocol to assess such biocompatibility existed for the infant care market, Eastman took the initiative to establish such a protocol.

Eastman Takes Biocompatibility Testing to a New Level

Eastman worked with Toxikon Corporation, a life sciences company specializing in compliance studies for product safety, to create a testing protocol that assesses the suitability of a product for contact with the body. See the test descriptions and results below.

This testing is the first of its kind to be provided to manufacturers of infant care products. Eastman believes these protocols should be adopted by the industry so that manufacturers of infant care products (even manufacturers who do not use Eastman Tritan™ EX401 copolyester) can provide the same high level of confidence to their customers.

A studied approach to consumer confidence.

Eastman has developedEastman Tritan™ EX401 copolyester addresses health and regulatory issues important to the infant-care market a protocol to evaluate the biocompatibility of materials intended for infant care applications based on steam sterilization.The following is a brief description of the testing, including the results achieved by Eastman Tritan™ EX401 copolyester. For additional information, visit us at www.eastman.com/tritan.

An agar diffusion test was conducted to evaluate the potential biological reactivity of mammalian cells in vitro. Mammalian cells were selected for this test because of their sensitivity to leachable cytotoxic substances. Results:There was no biological reactivity observed at 48 hours post-exposure. Under accepted guidelines, these results indicate that Eastman Tritan™ EX401 copolyester is non-cytotoxic.

Sensitization Reactions*
A direct-contact Buehler sensitization test was conducted to evaluate the potential to produce skin sensitization in mammalian tissue in vivo. Topical application was selected because it represents a likely route of human exposure for infant-care products. Results: No skin reactions or overt signs of toxicity were detected. Eastman Tritan™ EX401 copolyester is not considered a skin sensitizer.

Skin Irritation Responses*
A primary skin irritation test was conducted to evaluate the potential to produce primary dermal irritation after a single topical exposure. Dermal exposure was selected because it represents a likely route of human exposure for infant-care products. Results:There were no signs of erythema (redness) or edema (swelling) at any point during the observation period. Eastman Tritan™ EX401 copolyester is considered a negligible irritant.

For more information on the safety of Eastman Tritan™ copolyester, visit www.TritanSafe.com.

*All studies conducted in compliance with the current FDA 21 CFR, Part 58 – Good Laboratory Practice for Non-Clinical Laboratory Studies.

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