Elution of Plasticizers from Various Administration Sets after Passing Fat Emulsion through Them
The use of Tris (2-ethylhexyl) trimellitate (TOTM) as an alternative to di (2-ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC) medical devices is steadily increasing. Four types of administration sets are available : general-type sets made of PVC using DEHP (DEHP-PVC) or TOT...
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| Published in | Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) Vol. 31; no. 4; pp. 295 - 300 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
Japanese Society of Pharmaceutical Health Care and Sciences
2005
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1346-342X 1882-1499 |
| DOI | 10.5649/jjphcs.31.295 |
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| Abstract | The use of Tris (2-ethylhexyl) trimellitate (TOTM) as an alternative to di (2-ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC) medical devices is steadily increasing. Four types of administration sets are available : general-type sets made of PVC using DEHP (DEHP-PVC) or TOTM (TOTM-PVC) as a plasticizer, pump-type sets made of DEHP-PVC, and those made of polybutadiene (PB). Since the elution of plasticizer from administration sets when specific drugs are passed though them is a matter of concern, in the present study, we compared the amounts of plasticizer eluted from these 4 types of administration sets after passing fat emulsion through them, for different drip rate. The concentrations of plasticizer eluted were lowest for the TOTM-PVC administration set, followed in ascending order by the general-type DEHP-PVC and pump-type DEHP-PVC sets. Neither DEHP nor TOTM was detected for the PB set. For the general-type administration set, the maximum concentrations of TOTM and DEHP eluted were obtained with a drip rate of 10 mL/hr, which were 0.38μg/mL for TOTM and 10.32μg/mL for DEHP, respectively. At a drip rate of 80 mL/hr, the maximum concentration of DEHP was 0.97μg/mL but TOTM was not detected. These results indicate that TOTM is less easily eluted than DEHP and that TOTM-PVC is an excellent material for administration sets in view of its low elution characteristics, though care needs to be taken with regard to drug adsorption. |
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| AbstractList | The use of Tris (2-ethylhexyl) trimellitate (TOTM) as an alternative to di (2-ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC) medical devices is steadily increasing. Four types of administration sets are available : general-type sets made of PVC using DEHP (DEHP-PVC) or TOTM (TOTM-PVC) as a plasticizer, pump-type sets made of DEHP-PVC, and those made of polybutadiene (PB). Since the elution of plasticizer from administration sets when specific drugs are passed though them is a matter of concern, in the present study, we compared the amounts of plasticizer eluted from these 4 types of administration sets after passing fat emulsion through them, for different drip rate. The concentrations of plasticizer eluted were lowest for the TOTM-PVC administration set, followed in ascending order by the general-type DEHP-PVC and pump-type DEHP-PVC sets. Neither DEHP nor TOTM was detected for the PB set. For the general-type administration set, the maximum concentrations of TOTM and DEHP eluted were obtained with a drip rate of 10 mL/hr, which were 0.38μg/mL for TOTM and 10.32μg/mL for DEHP, respectively. At a drip rate of 80 mL/hr, the maximum concentration of DEHP was 0.97μg/mL but TOTM was not detected. These results indicate that TOTM is less easily eluted than DEHP and that TOTM-PVC is an excellent material for administration sets in view of its low elution characteristics, though care needs to be taken with regard to drug adsorption. |
| Author | Senshu, Kazuhisa Yonaiyama, Mio Koyama, Sawako |
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| References | 20) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのチャイニーズ・ハムスター培養細胞を用いる染色体異常試験, 化学物質毒性試験報告書4,717-720 (1996). 13) K. Rathinam, S.P. Srivastava and P.K. Seth, Hepatic studies of intraperioneally administered tri (2-ethylhexyl) trimellitate (TOTM) and di (2-ethylhexyl) phthalate in rats, Journal of Applied Toxicology, 10, 39-41 (1990). 10) L.M. Flaminio, L.D. Angelis, M. Ferazza, M. Marinovich, G. Galli, C.L. Galli, Leachability of a new plasticizer tris (2-ethylhexyl) trimellitate from haemodialysis tubing, The International Journal of Artificial Organs, 11,435-439 (1988). 21) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる単回経口投与毒性試験, 化学物質毒性試験報告書4,699-700 (1996). 9) 厚生労働省, 厚生労働科学研究費補助金 (医薬安全総合研究授業) 分担研究報告書, 血液接触型プラスチック製医療用具からの可塑剤溶出評価に関する研究, 配島由二 (2001年). 3) J.C. Lamb IV, R.E. Chapin, J. Teague, A.D. Lawton, L.R. Reel, Reproductive effects of four phthalic acid esters in the mouse, Toxicology and Applied Pharmacology, 88,255-269 (1987). 19) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルの細菌を用いる復帰突然変異試験, 化学物質毒性試験報告書4,713-716 (1996). 6) M.C. Allwood, The release of phthallate ester plasticizer from intravenous, administration sets into fat emulsion, International J of Pharmaceutics, 29,233-236 (1986). 2) R. Poon, P. Lecavalier, R. Mueller, V.E. Valli, B.G. Procter and I. Chu, Subchronic oral toxycity of di-noctyl phthalate and di (2-ethylhexyl) phthalate in the rat, Food and Chemical Toxicology, 35,225-239 (1997). 1) 環境庁 : 環境ホルモン戦略計画SPEED'98, 外因性内分泌攪乱化学物質問題への環境庁の対応方針について, 表3-1 (1998年5月). 5) 仲川義人, 点滴用器材と環境ホルモン, 医療廃棄物研究, 15, 1-9 (2002). 23) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる経口投与簡易生食毒性試験, 化学物質毒性試験報告書6,571-578 (1998). 24) 厚生科学研究, 高分子素材からなる生活関連製品由来の内分泌かく乱物質の分析及び動態解析主任研究者 : 中澤裕之 (H11-生活-023), 2001年. 7) 海老原光孝, 豊口禎子, 東海林徹, 仲川義人, ポリ塩化ビニル製輸液セットからの点滴液中への可塑剤溶出, 医薬品相互作用研究, 24, 3-8 (2000). 8) 田中睦子, 河野健治, 花輪剛久, 鈴木正彦, 中島新一郎, 経腸経管栄養療法時におけるポリ塩化ビニル製チューブからのフタル酸ジ-2-エチルヘキシルの溶出, 医療薬学, 28,152-156 (2002). 18) M.K. Elias, N. Blom, L. Rijskamp, M. Weggemans, M. R. Halie, P.C. Das, C.T. Sibinga, Evaluation of elutriated single donor platelets collected andstored in closed system, J. Clinical Apheresis, 7,183-190 (1992). 17) A. Byron, Survival of red cells stored for 21 and 35 days in a non-di (2-ethylhexyl) phthalate plastic container, Vox Sang, 53,199-202 (1987). 22) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる28日間反復経口投与毒性試験, 化学物質毒性試験報告書4,701-711 (1996). 12) J.R. Hodgson, Results of peroxisome induction studies on tri (2-ethylhexyl) trimellitate and 2-ethylhexanol, Toxicologyand Industrial Health, 3, 49-61 (1987). 11) 千秋和久, 竹中みお, 宮原八州子, 一石素子, 小山佐和子, トリメリット酸トリス-2-エチルヘキシルを可塑剤として含むポリ塩化ビニル製輸液セットにおける薬剤収着と可塑剤溶出に関する検討, 医療薬学, 30,136-142 (2004). 25) 大橋篤, 日比谷信, 堀秀生, 加藤政雄, 川口和紀, 村上和隆, 長谷川みどり, 富田亮, 長谷川寛, 鹿野昌彦, 杉山敏, DEHP代替可塑剤を用いた塩化ビニル回路の内分泌攪乱作用に関する基礎的研究, 日本透析医学会誌総会特別号, 649 (2002). 26) 幸保文治, 可塑剤にTOTM [Tris (2-ethylhexyl) trimellitate] を用いたポリ塩化ビニル (PVC) 製輸液セットへのニトログリセリンの収着とエトポシド注射液による可塑剤の溶出, 新薬と臨床, 52, 1110-1116 (2003). 15) 松尾保, 村上龍助, 新生児・未熟児の経腸栄養に関する研究, 静注用脂肪乳剤投与の評価, 厚生省心身障害研究報告書-新生児管理における諸問題の総合的研究, 76-81 (1984). 4) C. Wolf, C. Lambright, P. Mann, M. Price, R.L. Cooper, J. Ostby, L.E. Gray JR., Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodine, chlozolinate, p, p' -DDE, and ketoconazole) and toxicsubstance (dibutyl and diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiantion produces diverse profiles of reproductive malformations in the male rat, Toxicology and Industrial Health, 15, 94-118 (1999). 14) 米国FDA, DEHPに関する安全性評価レポート, Safety Assessment of Di (2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices, 3-5 (2001). 16) 水田祥代, 小児の術前・術後の栄養管理, 「高カロリーの適正使用」Chapter 6, 17-19 (2002). |
| References_xml | – reference: 23) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる経口投与簡易生食毒性試験, 化学物質毒性試験報告書6,571-578 (1998). – reference: 15) 松尾保, 村上龍助, 新生児・未熟児の経腸栄養に関する研究, 静注用脂肪乳剤投与の評価, 厚生省心身障害研究報告書-新生児管理における諸問題の総合的研究, 76-81 (1984). – reference: 14) 米国FDA, DEHPに関する安全性評価レポート, Safety Assessment of Di (2-ethylhexyl) phthalate (DEHP) Released from PVC Medical Devices, 3-5 (2001). – reference: 4) C. Wolf, C. Lambright, P. Mann, M. Price, R.L. Cooper, J. Ostby, L.E. Gray JR., Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodine, chlozolinate, p, p' -DDE, and ketoconazole) and toxicsubstance (dibutyl and diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiantion produces diverse profiles of reproductive malformations in the male rat, Toxicology and Industrial Health, 15, 94-118 (1999). – reference: 9) 厚生労働省, 厚生労働科学研究費補助金 (医薬安全総合研究授業) 分担研究報告書, 血液接触型プラスチック製医療用具からの可塑剤溶出評価に関する研究, 配島由二 (2001年). – reference: 12) J.R. Hodgson, Results of peroxisome induction studies on tri (2-ethylhexyl) trimellitate and 2-ethylhexanol, Toxicologyand Industrial Health, 3, 49-61 (1987). – reference: 21) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる単回経口投与毒性試験, 化学物質毒性試験報告書4,699-700 (1996). – reference: 2) R. Poon, P. Lecavalier, R. Mueller, V.E. Valli, B.G. Procter and I. Chu, Subchronic oral toxycity of di-noctyl phthalate and di (2-ethylhexyl) phthalate in the rat, Food and Chemical Toxicology, 35,225-239 (1997). – reference: 11) 千秋和久, 竹中みお, 宮原八州子, 一石素子, 小山佐和子, トリメリット酸トリス-2-エチルヘキシルを可塑剤として含むポリ塩化ビニル製輸液セットにおける薬剤収着と可塑剤溶出に関する検討, 医療薬学, 30,136-142 (2004). – reference: 17) A. Byron, Survival of red cells stored for 21 and 35 days in a non-di (2-ethylhexyl) phthalate plastic container, Vox Sang, 53,199-202 (1987). – reference: 1) 環境庁 : 環境ホルモン戦略計画SPEED'98, 外因性内分泌攪乱化学物質問題への環境庁の対応方針について, 表3-1 (1998年5月). – reference: 7) 海老原光孝, 豊口禎子, 東海林徹, 仲川義人, ポリ塩化ビニル製輸液セットからの点滴液中への可塑剤溶出, 医薬品相互作用研究, 24, 3-8 (2000). – reference: 22) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのラットを用いる28日間反復経口投与毒性試験, 化学物質毒性試験報告書4,701-711 (1996). – reference: 8) 田中睦子, 河野健治, 花輪剛久, 鈴木正彦, 中島新一郎, 経腸経管栄養療法時におけるポリ塩化ビニル製チューブからのフタル酸ジ-2-エチルヘキシルの溶出, 医療薬学, 28,152-156 (2002). – reference: 13) K. Rathinam, S.P. Srivastava and P.K. Seth, Hepatic studies of intraperioneally administered tri (2-ethylhexyl) trimellitate (TOTM) and di (2-ethylhexyl) phthalate in rats, Journal of Applied Toxicology, 10, 39-41 (1990). – reference: 6) M.C. Allwood, The release of phthallate ester plasticizer from intravenous, administration sets into fat emulsion, International J of Pharmaceutics, 29,233-236 (1986). – reference: 19) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルの細菌を用いる復帰突然変異試験, 化学物質毒性試験報告書4,713-716 (1996). – reference: 3) J.C. Lamb IV, R.E. Chapin, J. Teague, A.D. Lawton, L.R. Reel, Reproductive effects of four phthalic acid esters in the mouse, Toxicology and Applied Pharmacology, 88,255-269 (1987). – reference: 18) M.K. Elias, N. Blom, L. Rijskamp, M. Weggemans, M. R. Halie, P.C. Das, C.T. Sibinga, Evaluation of elutriated single donor platelets collected andstored in closed system, J. Clinical Apheresis, 7,183-190 (1992). – reference: 10) L.M. Flaminio, L.D. Angelis, M. Ferazza, M. Marinovich, G. Galli, C.L. Galli, Leachability of a new plasticizer tris (2-ethylhexyl) trimellitate from haemodialysis tubing, The International Journal of Artificial Organs, 11,435-439 (1988). – reference: 25) 大橋篤, 日比谷信, 堀秀生, 加藤政雄, 川口和紀, 村上和隆, 長谷川みどり, 富田亮, 長谷川寛, 鹿野昌彦, 杉山敏, DEHP代替可塑剤を用いた塩化ビニル回路の内分泌攪乱作用に関する基礎的研究, 日本透析医学会誌総会特別号, 649 (2002). – reference: 24) 厚生科学研究, 高分子素材からなる生活関連製品由来の内分泌かく乱物質の分析及び動態解析主任研究者 : 中澤裕之 (H11-生活-023), 2001年. – reference: 5) 仲川義人, 点滴用器材と環境ホルモン, 医療廃棄物研究, 15, 1-9 (2002). – reference: 26) 幸保文治, 可塑剤にTOTM [Tris (2-ethylhexyl) trimellitate] を用いたポリ塩化ビニル (PVC) 製輸液セットへのニトログリセリンの収着とエトポシド注射液による可塑剤の溶出, 新薬と臨床, 52, 1110-1116 (2003). – reference: 16) 水田祥代, 小児の術前・術後の栄養管理, 「高カロリーの適正使用」Chapter 6, 17-19 (2002). – reference: 20) 厚生省, 1, 2, 4, -ベンゼントリカルボン酸トリス (2-エチルヘキシル) エステルのチャイニーズ・ハムスター培養細胞を用いる染色体異常試験, 化学物質毒性試験報告書4,717-720 (1996). |
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| Title | Elution of Plasticizers from Various Administration Sets after Passing Fat Emulsion through Them |
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| ispartofPNX | Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences), 2005/04/10, Vol.31(4), pp.295-300 |
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