Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to D-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes

EFSA Journal

Volumn 5, Issue 5, 2007, Pages

[No Author Info available]

Author keywords

CAS Registry Number 9002 96 4; D alpha tocopheryl polyethylene glycol 1000 succinate (TPGS); foods for particular nutritional uses; supplement for foods for special medical purposes; vitamin E deficiency; water soluble vitamin E

Indexed keywords

EID: 85062099490     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2007.490     Document Type: Article

References (36)

1. Argao, E A, Heubi, J E, Hollis, B W and Tsang, R C (1992) D-α-Tocopherol polyethylene glycol-1000 succinate enhances the absorption of vitamin D in chronic cholestatic liver disease of infancy and childhood. Pediatric Research 31 (2): 146–150 1992
2. Argao, E.A. and Heubi, J.E. (1993). Fat-soluble vitamin deficiency in infants and children. Current Opinion in Pediatrics, 5, 5623–566.
3. Beath, S.V., Brook, G., Kelly, D.A. et al., (1993) Succesful liver transplantation in babies under one year, British Medical Journal, 307, 825–828.
4. Carini, R., Poli, G., Dianzani, M.U.,
5. Collnot, E.M., Baldes, C., Wempe, M.F., Hyatt, J., Navarro, L., Edgar, K.J., Schaefer, U.F. and Lehr, C-M. (2006). Influence of vitamin E TPGS poly(ethyleneglycol) chain length on apical efflux transporters in Caco-2 cell monolayers. J. Controlled Release, 111, 35–40.
6. Dimitrov, N.V., Meyer-Leece, C., Mcmillan, J., Gilliland, D., Perloff, M. and Malone, W. (1996). Plasma α-tocopherol concentrations after supplementation with water- and fat-soluble vitamin E. Am. J. Clin Nutr., 64, 329–335.
7. EFSA (2005) Opinion of the AFC Panel related to D-α-tocopheryl acid succinate as a source of vitamin E in foods intended for the general population, food supplements and foods for particular nutritional uses. Question Nr. EFSA-Q-2003-074. Adopted on 26 April 2005 The EFSA Journal, 203, 1–16 www.efsa.europa.eu/en/science/afc/afc_opinions/925.html
8. EFSA (2006). Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of polyethylene glycol (PEG) as a film coating agent for use in food supplement products. Question No EFSA-Q-2005-277. Adopted on 28 November 2006. The EFSA Journal, 414, 1-22. www.efsa.europa.eu/en/science/afc/afc_opinions/ej414_polyethyleneglycol.html
9. Holt R.I., Broide, E., Buchanan, C.R. et al., (1997). Orthotopic liver transplantation reverses the adverse nutritional changes of end-stage liver disease in children. American Journal of Clinical Nutrition, 65, 534–542.
10. Krasavage, W.J. and Clarence J. Terhaar. (1977). D-α-tocopheryl poly(ethylene glycol) 1000 succinate. Acute toxicity, subchronic feeding, reproduction and teratology studies in the rat. J. Agric. Food Chem., 25, 273–278.
11. Ludwig, M.I., Ames, S.R. (1959). The physiological activity of d-alpha-tocopheryl polyethylene glycol 1000 succinate. laboratory report number 665, December 18, 1959. Distillation Products Industries, Division of Eastman Kodak Campany, Rochester, NY, USA.
12. SCF, EC Scientific Committee for Food (1993). Nutrient and energy intakes for the European Community. Reports of the Scientific Committee for Food (Thirty-first series). European Commission, Luxembourg. Available at ec.europa.eu/food/fs/sc/scf/out89.pdf
13. Shepard, K.P. Acute toxicity of vitamin E TPGS., HAEL No. 89–0117, November 28, 1989. Toxicological Sciences Laboratory, Health and Environment Laboratories, Eastman Kodak Caompany, Rochester, NY, USA.
14. Socha, P., Koletzko, B., Pawlowska, J., Proszynska, K. and Socha, J. (1997). Treatment of cholestatic children with water-soluble vitamin E (α- tocopherol polyethylene glycol succinate): Effects on serum vitamin E, lipid peroxides, and polyunsaturated fatty acids. J. Pediatric Gastroenterology and Nutrition, 24, 189–193.
15. Sokol, R.J., Guggenheim, M., Iannacone, S.T., Barkhaus, P.E., Miller, C.V., Balistreri, W.F. and Heubi, M.D. (1985). Improved neurological function after long-term correction of vitamin E deficiency in children with chronic cholestasis. The New England Journal of Medicine, 313, 1580–1586.
16. Sokol, R.J., Heubi, J.E., Butler-Simon, N.A., McClung, H.J., Lilly, J.R. and Silverman, A. (1987a). Treatment of vitamin E deficiency during chronic childhood cholestasis with oral d-α-tocopheryl polyethylene glycol-1000 succinate. Gastroenterology, 93, 975–985.
17. Sokol, R.J., Butler-Simon, N.A., Bettis, D, Smith, D.J. and Silverman, A. (1987b). Tocopheryl polyethylene glycol 1000 succinate therapy for vitamin E deficiency during chronic childhood cholestasis: Neurologic outcome. J. Pediatr., 111, 830–836.
18. Sokol, R.J. and Stall, C. (1990). Anthropometrics evaluation of children with chronic liver disease. American Journal of Clinical Nutrition, 52, 203–208.
19. Sokol, R.L., Butler-Simon, N.A., Conner, C., Heubi, J.E., Suchy, F.J., Heyman, M.B., Perrault, J., Rothbaum, R.J., Levy, J., Iannacone, S.T., Shneider, Koch, T.K. and Narkewicz, M.R. (1993). Multicenter trailk of d-α- tocopherol polyethylene glycol 1000 succinate for treatment of vitamin E deficiency in children with chronic cholestasis. Gastroenterology, 104, 1727–1735.
20. Traber, M.G., Kayden, H.J., Balmer Green, J. and Green M.H. (1986). Absorption of water-miscible forms of vitamin E in a patient with cholestasis and in thoracic duct-cannulated rats. Am. J. Clin. Nutr., 44, 914–923.
21. Traber, M.G., Thelleman, C.A., Rindler, M.J. and Kayden, H.J. (1988). Uptake of intact PTPGS (D-α- tocopherol polyethylene glycol 1000 succinate) a wtaer-miscible form of vitamin E by humans cells in vitro. Am. J. Clin. Nutr., 48, 605–611.
22. Traber, M.G., Schiano, T.D., Steephen, A.C., Kayden, H.J. and Shike, M. (1994). Efficacy of water-soluble vitamin E in the treatment of vitamin E malabsorption in short-bowel syndrome. Am. J. Clin. Nutr., 59, 1270–1274.
23. 14C] polyethylene glycol 1000 succinate in rats (1988a). March 14, 1988, Technical Report # DM8805, Eastman Pharmaceuticals Drug Safety Evaluation.
24. 14C] polyethylene glycol 1000 succinate in rats (1988b). March 24, 1988, Technical Report # DM8807, Eastman Pharmaceuticals Drug Safety Evaluation.
25. 14C] polyethylene glycol 1000 succinate in rats (1988c). March 23, 1988, Technical Report # DM8806, Eastman Pharmaceuticals Drug Safety Evaluation.
26. NCI National Cancer Institute (1994a) One year chronic study in rats. Conducted at International Research and Development Corporation, Mattawan MI 49071, November1, 1994 (IRDC report 560–040) for the National Cancer Institute, Bethesda, MD 20892. USA.
27. NCI National Cancer Institute (1994b) One year chronic study in dogs. Conducted at International Research and Development Corporation, Mattawan MI 49071, November1, 1994 (IRDC report 560–041) for the National Cancer Institute, Bethesda, MD 20892. USA.
28. Serota, D.G. and Slone, T.W. (2003a). 2-year oral carcinogenicity study of excipient containing 23 % TPGS in the mouse. Report of MPI Research Study Number 777–003, submitted by Eastman Chemical Company
29. Serota, D.G. and Slone, T.W. (2003b). 2-year oral carcinogenicity study of excipient containing 23 % TPGS in the rat. Report of MPI Research Study Number 777–004, submitted by Eastman Chemical Company
30. SRICC (Safety Research Institute for Chemical Compounds Co.) (1998a). Bacterial Reverse Mutation test of TPGS. Study #SR- 9807, September 22, 1998. SRICC, Ltd Sapporo, Hokkaido, Japan.
31. SRICC (Safety Research Institute for Chemical Compounds Co.) (1998b). Chromosal Aberration test of TPGS. Study #SR- 9808, October 28, 1998. SRICC, Ltd Sapporo, Hokkaido, Japan.
32. SRICC (Safety Research Institute for Chemical Compounds Co.) (1998c). Micronucleus Test of TPGS in rats. Study #SR- 9809, September 22, 1998. SRICC, Ltd Sapporo, Hokkaido, Japan.
33. SRICC (Safety Research Institute for Chemical Compounds Co.) (1999a). Single Dose Oral Toxicity Study of TPGS in Beagle Dogs. Study #SR- 9810, March 5, 1999. SRICC, Ltd Sapporo, Hokkaido, Japan.
34. SRICC (Safety Research Institute for Chemical Compounds Co.) (1999b). Study of TPGS for Effects on Embryo-Fetal Development in Rabbits. Study #SR- 9812, March 29, 1999. SRICC, Ltd Sapporo, Hokkaido, Japan.
35. SRICC (Safety Research Institute for Chemical Compounds Co.) (1999c). Additional Study of TPGS for Effects on Embryo-Fetal Development in Rabbits. Study #SR-9853, March 29, 1999. SRICC, Ltd Sapporo, Hokkaido, Japan.
36. SRICC (Safety Research Institute for Chemical Compounds Co.) (1999d). Study of TPGS for Effects on Embryo-Fetal Development and Pre- and Post-natal Development, Including Maternal Function in rats. Study #SR- 9813, March 29, 1999. SRICC, Ltd Sapporo, Hokkaido, Japan.