diplast_tm-mg
Transcript
diplast_tm-mg
Polynt S.p.A. – Stab. S. Giovanni V.no Via del Pruneto, 40 IT-52027 San Giovanni V.no (AR) Phone +39 055 91281 Fax +39 055 943936 Sede Legale Via Enrico Fermi, 51 IT-24020 Scanzorosciate (BG) Phone +39 035 65211 Fax +39 035 652421 Technical data sheet DIPLAST® TM/MG Version: November 2015 Chemical composition Tri-2-ethylhexyl trimellitate (TOTM or TEHTM) CAS number 3319-31-1 EINECS number 222-020-0 Specifications Characteristics Density at 20°C Refractive index n20D Colour Acidity Water content Ester content U.V. absorbance on aqueous extract Reducing substances on aqueous extract Unit Value Test method g/ml 0.987-0.990 GM 012 ASTM D 4052-96 1.485-1.487 GM 020 ASTM D 1045-95 Pt-Co 30 max. PL02F ASTM D 1045-95 ASTM D 1209-00 mgKOH/g 0.1 max. PL02C ASTM D 1045-95 % 0.1 max. GM 010 ASTM E 203-96 % 99.5 min. PL10C G.C. 0.1 max. PL03C ml 1.0 max. PL05C The DIPLAST TM/MG is a pale yellow liquid, anhydrous, clear and free from matter in suspension. It is miscible with common organic solvents but immiscible with water and miscible with most of the plasticizers used in processing PVC. The product DIPLAST TM/MG due to its nature does not have a shelf life. However it can be stored in appropriate containers at a temperature of approximately 25°C and the exclusion of humidity for at least 1 year, without losing its chemical properties. Technical Data Sheet ® DIPLAST TM/MG Version n° 04 November-06-2015 First emission : October 2006 Page 1 / 5 Polynt S.p.A. – Stab. S. Giovanni V.no Via del Pruneto, 40 IT-52027 San Giovanni V.no (AR) Phone +39 055 91281 Fax +39 055 943936 Sede Legale Via Enrico Fermi, 51 IT-24020 Scanzorosciate (BG) Phone +39 035 65211 Fax +39 035 652421 General characteristics Characteristics Viscosity at 20°C Saponification number Volatility 6 hours at 100°C Unit Value Test method mPa·s mgKOH/g 305 307 GM 022 PL08C % 0.01 PL07F ppm ppm ppm ppm ppm ppm °C <1 <1 <3 <1 < 0.6 <1 > 250 ASTM D 445-96 BS 4835 (7 grams in 75 mm Petri dish) Heavy metals content • Chromium • Barium • Tin • Lead • Cadmium • Copper Flash point The figures above are typical values and are not intended as specification limits. For further information on the characteristics and properties of DIPLAST TM/MG in the liquid state, see the relevant EC-standard Materials Safety Data Sheet. DIPLAST TM/MG is a high purity, antioxidant free grade of TEHTM. DIPLAST TM/MG is manufactured under appropriate procedures of production, quality control and deliveries in accordance with management system for Quality and Environment (ISO 9001 and ISO 14001). Characteristics and applications of DIPLAST TM/MG. DIPLAST TM/MG is the grade Polynt recommends when TEHTM is required for PVC medical compounds manufacturing. According to the actual European legislation, TEHTM is not listed in the Pharmacopoeia as a plasticizer to be used in the production of medical devices. However, THETM’s use as a DEHP’s alternative is well known to those skilled in the art and is largely reported in the relevant literature. TEHTM, in addition to its good workability and efficiency, has a good extraction resistance, good compatibility in high humidity conditions, very low volatility and also a good migration resistance, superior than the phthalates’ one, in contact with several materials. Technical Data Sheet ® DIPLAST TM/MG Version n° 04 November-06-2015 First emission : October 2006 Page 2 / 5 Polynt S.p.A. – Stab. S. Giovanni V.no Via del Pruneto, 40 IT-52027 San Giovanni V.no (AR) Phone +39 055 91281 Fax +39 055 943936 Sede Legale Via Enrico Fermi, 51 IT-24020 Scanzorosciate (BG) Phone +39 035 65211 Fax +39 035 652421 The properties of TEHTM in comparison with those of DIPLAST O/MG (DEHP) are listed in tab.1 using the following formulation: Formulation PHR (parts by weight) PVC K70 Plasticizer Ca/Zn Stearic acid The specimens were prepared by calendering and moulding to obtain the the different test methods. 100 50 1.2 0.3 thickness required for Results Tab.1 Shore “A” hardness Cold flex °C (Clash & Berg) Brittle point Solution Temperature °C (*) Extraction resistance -% weight loss-(48h at 70°C) Water Aqueous soap 1% Olive oil Mineral oil n-Hexane (24hours at 23°C) Volatility (7days at 100°C) Rheological properties Dryblending time 83°C (Mixer P-600 : 100 RPM) Gel time 88°C (at max torque) (Mixer W-50; 40 rpm; 48gr) Fusion Temperature (°C) (Mixer W-50, 5°C/min, 40Rpm) Test method DIPLAST TM/MG DIPLAST O/MG ISO 868 88 80 ISO/R 458 -20 -26 ISO 974 -30 -25 DIN 53408 140.5 120 -0.1 -0.1 -3.5 -2.8 -27.8 -0.1 -3.4 -7 -6.2 -27.3 ISO 176 -1.1 -13.4 Brabender Plasticorder 5’15” 2’38” Brabender Plasticorder Brabender Plasticorder 9’45” 5’12” 118.5 114 ISO 175 (*) Solution temperature determined with dispersion of resin: two grams of PVC are placed in 48 grams of plasticizer and the solution is heated at 1°C/min. Technical Data Sheet ® DIPLAST TM/MG Version n° 04 November-06-2015 First emission : October 2006 Page 3 / 5 Polynt S.p.A. – Stab. S. Giovanni V.no Via del Pruneto, 40 IT-52027 San Giovanni V.no (AR) Phone +39 055 91281 Fax +39 055 943936 Sede Legale Via Enrico Fermi, 51 IT-24020 Scanzorosciate (BG) Phone +39 035 65211 Fax +39 035 652421 Shore "A" Hardness DEHP vs TEHTM 100 Shore "A" 90 80 70 60 35 55 PHR 45 65 DEHP 75 TEHTM Cold flex - Clash & Berg (ISO/R 458) DEHP vs TEHTM 0 -5 -10 -15 °C -20 -25 -30 -35 -40 -45 35 45 DEHP 55 PHR 65 75 TEHTM Due to its better characteristics of volatility and extraction resistance, TEHTM can be considered highly permanent plasticizer for PVC. This property is particularly important for the applications in medical devices, since it reduces the leachability of the plasticizer from the medical device to its content (blood or its derivatives) and the subsequent transfer and accumulation in the human body (ref. 1; ref. 2). These properties, together with a better biocompatibility and good gas permeability (ref. 3; ref. 4) are described in the listed literature (see below). Technical Data Sheet ® DIPLAST TM/MG Version n° 04 November-06-2015 First emission : October 2006 Page 4 / 5 Polynt S.p.A. – Stab. S. Giovanni V.no Via del Pruneto, 40 IT-52027 San Giovanni V.no (AR) Phone +39 055 91281 Fax +39 055 943936 Sede Legale Via Enrico Fermi, 51 IT-24020 Scanzorosciate (BG) Phone +39 035 65211 Fax +39 035 652421 References Ref. 1 Author: Kambia, K.; Dine, T.; Azar, R.; Gressier, B.; Luyckx, M.; Brunet, C. Title: Comparative study of the leachability of di(2-ethylhexyl) phthalate and tri(2ethylhexyl) trimellitate from hemodialysis tubing. Organization: Laboratoire de Pharmacologie, Faculte des Sciences Pharmaceutiques et Biologiques, Pharmacocinetique et Pharmacie Clinique, Lille, 59006, Fr. Publication Source: International Journal of Pharmaceutics (2001), 229(1-2), 139-146 Ref.2 Author: Senshu, Kazuhisa; Takenaka, Mio; Miyahara, Yasuko; Ichiishi, Motoko; Koyama, Sawako Title: Study on drug sorption of polyvinyl chloride-infusion line containing tris(2ethylhexyl) trimellitate as the plasticizer and release behavior of the plasticizer. Organization: R+D Center, Terumo Corporation, Japan. Publication Source: Iryo Yakugaku (2004), 30(2), 136-142 Ref. 3 US Patent 4280497 Ref. 4 US Patent 6060138 Ref. 5 Author: Ohashi, Atsushi; Kotera, Hirohisa; Hori, Hideo; Hibiya, Makoto; Watanabe, Koji; Murakami, Kazutaka; Hasegawa, Midori; Tomita, Makoto; Hiki, Yoshinobu; Sugiyama, Satoshi Title: Evaluation of endocrine disrupting activity of plasticizers in polyvinyl chloride tubes by estrogen receptor alpha binding assay Organization: Department of Clinical Biochemistry, Fujita Health University College, 1-98 Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan. Publication Source: Journal of Artificial Organs (2005), 8(4), 252-256. Ref. 6 Author: Kambia, K.; Dine, T.; Dupin-Spriet; Gressier, B.; Luyckx, M.; Brunet, C.. Title: Evaluation of the direct toxicity of trioctyltrimellitate (TOTM), di(2-ethylhexyl) phthalate (DEHP) and their hydrolysis products on isolated rat hepatocytes. Organization: Laboratoire de Pharmacologie, Pharmacocinetique et Pharmacie clinique, Faculte des Sciences Pharmaceutiques et Biologiques, Lille, Fr.. Publication Source: International Journal of Artificial Organs (2004), 27(11), 971-978 The information contained here is correct and accurate and is based on our technical and scientific knowledge at the date of going to press. Such information is, in all cases, relevant only with respect to the product as used in its pure state and only for the uses referred to in this publication. Nothing stated here may be taken or construed as implying a breach of existing patents. No warranty, either expressed or implicit, is given with regard to the results to be obtained from using this information. Technical Data Sheet ® DIPLAST TM/MG Version n° 04 November-06-2015 First emission : October 2006 Page 5 / 5