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