Characterization of alternative plasticizers in poly(vinyl chloride) sheets for blood containers |
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| Authors: | Yuji Haishima Tsuyoshi Kawakami Chie Fukui Akito Tanoue Toshiyasu Yuba Satoru Ozono Hidehumi Kumada Kaoru Inoue Tomomi Morikawa Miwa Takahashi Ayano Fujisawa Kayo Yamasaki Yusuke Nomura Kazuo Isama Ung‐il Chung Kumiko Ogawa Shingo Niimi Midori Yoshida |
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| Affiliation: | 1. Division of Medical Devices, National Institute of Health Sciences, Setagaya‐ku, Tokyo, Japan;2. Division of Environmental Chemistry, National Institute of Health Sciences, Setagaya‐ku, Tokyo, Japan;3. Department of Pharmacology, National Center for Child Health and Development, Setagaya‐ku, Tokyo, Japan;4. Corporate Research and Development Division, Kawasumi Laboratories, Inc., Shinagawa Intercity Tower B, Minato‐ku, Tokyo, Japan;5. Department of Dental Education, Kanagawa Dental University, Yokosuka, Kanagawa, Japan;6. Division of Pathology, National Institute of Health Sciences, Setagaya‐ku, Tokyo, Japan;7. Department of Bioengineering, The University of Tokyo Graduate Schools of Engineering and Medicine, Bunkyo‐ku, Tokyo, Japan;8. Research Department, Public Welfare Institute of Scientific Research Foundation, Koganei, Tokyo, Japan |
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| Abstract: | This study aimed to optimize the ratio of dioctyl 4‐cyclohexene‐1,2‐dicarboxylate (DOTH) and di‐isononyl‐cyclohexane‐1,2‐dicarboxylate (DINCH®) for use as plasticizers in poly(vinyl chloride) (PVC) sheets. We also evaluated the biological safety of DOTH for its potential to be part of a safe PVC‐based blood container. The suppression of hemolysis in mannitol‐adenine‐phosphate / red cell concentrates (MAP/RCC) with DOTH/(DINCH®‐PVC) sheets and the elution of plasticizers from the sheets increased with higher DOTH compositions. The properties of the PVC sheet containing DOTH and DINCH® in the ratio of 25:33 parts against PVC 100 parts as a weight were almost identical to the PVC sheet made of di(2‐ethylhexyl) phthalate. From a subchronic toxicity test, DOTH did not show any adverse effects on all organs, including the testes, epididymis, liver, and kidneys. The no‐observed‐adverse‐effect level was 300 mg/kg body weight/day in a rat. These results suggest that DOTH/DINCH® (25:33) is a promising candidate for the replacement of di(2‐ethylhexyl) phthalate in blood containers. J. VINYL ADDIT. TECHNOL., 22:520–528, 2016. © 2015 Society of Plastics Engineers |
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