Chronic oral toxicity of N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-l-phenylalanine 1-methyl ester, monohydrate (advantame) in the dog

Food and Chemical Toxicology

Volumn 49, Issue SUPPL. 1, 2011, Pages

  Otabe, A ^a   Fujieda, T ^a   Masuyama, T ^a  

^a AJINOMOTO CO INC   (Japan)

Author keywords

Advantame; Beagle dog; Chronic toxicity; N N 3 (3 hydroxy 4 methoxyphenyl) propyl aspartyl l phenylalanine 1 methyl ester

Indexed keywords

ADVANTAME; SWEETENING AGENT; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; BLOOD EXAMINATION; BODY WEIGHT; CHRONIC TOXICITY; CLINICAL CHEMISTRY; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DOG; EYE EXAMINATION; FEMALE; FOOD INTAKE; HISTOPATHOLOGY; MALE; MORTALITY; NONHUMAN; ORGAN WEIGHT; SEX DIFFERENCE; TOXICITY TESTING; TOXICOKINETICS; URINALYSIS;

ADMINISTRATION, ORAL; ANIMALS; DIPEPTIDES; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; MALE; SWEETENING AGENTS;

CANIS FAMILIARIS;

EID: 80755155762     PISSN: 02786915     EISSN: 18736351     Source Type: Journal    
DOI: 10.1016/j.fct.2011.06.044     Document Type: Article

References (19)

1. Angervall L., Carlström E. Theoretical criteria for the use of relative organ weights and similar ratios in biology. J. Theor. Biol. 1963, 4:254-259.
2. Bartlett M.S. Properties of sufficiency and statistical tests. Proc. R. Soc. Lond. A. Math. Phys. Sci. 1937, 160:268-282.
3. Dunnett C.W. A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 1955, 50:1096-1121.
4. Dunnett C.W. New tables for multiple comparisons with a control. Biometrics 1964, 20:482-491.
5. Fisher R.A. Statistical Methods for Research Workers 1973, Hafner Publishing Company, New York, p. 96. fourteenth ed.
6. Hayes T.J., Roberts G.K., Halliwell W.H. An idiopathic febrile necrotizing arteritis syndrome in the dog: beagle pain syndrome. Toxicol. Pathol. 1989, 17:129-137.
7. Healey G.F. The F1 Approximate Parametric Test for Monotonicity. Internal Technical Information Document ST9725 1999, Huntingdon Life Sciences, Department of Statistics.
8. Healey G.F. The H1 Approximate Parametric Test for Monotonicity. Internal Technical Information Document ST9726 1999, Huntingdon Life Sciences, Department of Statistics.
9. HLS, 2002 [unpublished]. ANS9801 Toxicity study by dietary administration to beagle dogs for 4 weeks, Huntingdon Life Sciences Ltd., Huntingdon, Engl. Study sponsored by: Ajinomoto Co. Inc., Tokyo 104, Japan. Report No. AJO 156/012585, issued April 19, 2002.
10. HLS, 2005 [unpublished]. Advantame (ANS9801) Toxicity study by dietary administration to beagle dogs for 13 weeks followed by a 4 week recovery period, Huntingdon Life Sciences Ltd., Huntingdon, Engl. Study sponsored by: Ajinomoto Co. Inc., Tokyo, Japan. Report No. AJO 156/012585, issued April 24, 2005.
11. JECFA, 2004. Safety Evaluation of Certain Food Additives and Contaminants: Sixty-first meeting of the Joint FAO/WHO Expert Committee on Food Additives June 10-19, 2003, Rome. Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO), Geneva, Switz., WHO Food Additives Series, No. 52, pp. 85-135.
12. Shirley E.A.C. A non-parametric equivalent of Williams' test for contrasting increasing dose levels of a treatment. Biometrics 1977, 33:386-389.
13. Son W.C. Idiopathic canine polyarteritis in control beagle dogs from toxicity studies. J. Vet. Sci. 2004, 5:147-150.
14. Steel R.G.D. A multiple comparison rank sum test: treatments versus control. Biometrics 1959, 15:560-572.
15. Thomford, P., Carter, J., 1997 [unpublished]. 52-week Dietary Toxicity Study of NC-00723 in Dogs followed by a 4-week Reversibility Period Study No. PCR 1017. Report from Covance Laboratories Inc., Madison, WI. Submitted to WHO by The NutraSweet Company, IL. Cited in: JECFA, 2004.
16. US FDA, 2008. Part 172-Food additives permitted for direct addition to food for human consumption §172.829-Neotame, US Code of Federal Regulations (CFR) Title 21: Food and Drugs (US Food and Drug Administration) Government Printing Office (GPO), Washington (DC), pp. 86-87. Available from: <>. http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfr172_08.html.
17. Ubukata, K., Nakayama, A., Mihara, R., 2011. Pharmacokinetics and metabolism of N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-l-phenylalanine 1-methyl ester, monohydrate (advantame) in the rat, dog, and man. Food Chem. Toxicol. doi:10.1016/j.fct.2011.06.042.
18. Williams D.A. A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 1971, 27:103-117.
19. Williams D.A. The comparison of several dose levels with a zero dose control. Biometrics 1972, 28:519-531.