Extension of the 4-week safety study for detecting immune system impairment appears not necessary: Example of cyclosporin A in rats

Toxicology

Volumn 112, Issue 3, 1996, Pages 245-256

  Descotes, Gérard ^a,d   Pinard, Dominique ^b   Gallas, Jean François ^a   Penacchio, Evelyne ^a   Blot, Christian ^c   Moreau, Christine ^a  

^a Sanofi Winthrop ^*  (United States)

^b UNIVERSITÉ DE BOURGOGNE   (France)

^c INSERM   (France)

^d INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

Author keywords

Conventional 4 week study; Cyclosporin A; Immunotoxicity (immunomodulation) evaluation; OECD guideline 407; Rat

Indexed keywords

CYCLOSPORIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG SAFETY; DRUG SCREENING; FEMALE; IMMUNE SYSTEM; IMMUNIZATION; IMMUNOTOXICITY; INTRAGASTRIC DRUG ADMINISTRATION; LEUKOCYTE COUNT; LYMPHOCYTE COUNT; MALE; MESENTERY LYMPH NODE; NATURAL KILLER CELL; NEPHROTOXICITY; NONHUMAN; PLAQUE FORMING CELL; PRIORITY JOURNAL; RAT; SEX DIFFERENCE; SHEEP ERYTHROCYTE; SPLEEN CELL; WEIGHT GAIN;

ANIMALIA; OVIS ARIES; RATTUS NORVEGICUS;

EID: 0030565504     PISSN: 0300483X     EISSN: None     Source Type: Journal    
DOI: 10.1016/0300-483X(96)03407-5     Document Type: Article

References (23)

1. Baldwin, W.M., Hutchison, I.F., Meijer, C.J.L. and Tilney, N.L. (1981) Immune responses to organ allografts. Marked decrease in medullary thymocytes and splenic T lymphocytes after cyclosporin A treatment. Transplantation 31, 117-120.
2. Benko, V., Wagner, V., Wagnerova, M. and Zavaral, V. (1986) Human exposure to nickel and cobalt: biological monitoring and immunochemical response. Environ. Res. 40, 399-410.
3. Beschorner, W.E., Namnoum, J.D., Hess, A.D., Shinn, C.A. and Santos, G.W. (1987) Cyclosporin A and the thymus. Immunopathology. Am. J. Pathol. 126, 487-496.
4. Blair, J.T., Thomson, A.W., Whiting, P.M., Davidson, R.J.L. and Simpson, J.G. (1982) Toxicity of the immune-suppressant cyclosporin A in the rat. J. Pathol. 138, 163-178.
5. Chambers, W.H., Vujanovic, N.L., DeLeo, A.B., Olszowy, M.W., Herberman, R.B. and Hiserodt, J.C. (1989) Monoclonal antibody to a triggering structure expressed on rat natural killer cells and adherent lymphokine-activated killer cells. J. Exp. Med. 169, 1373-1389.
6. Dean, J.H., Luster, M.I., Boorman, G.A. and Lauer, L.D. (1982) Procedures available to examine the immunotoxicity of chemicals and drugs. Pharmacol. Rev. 34, 137-148.
7. Descotes, G. and Mazué, G. (1987) Immunotoxicology. In: C.E. Cornelius, C.F. Simpson and A.G. Rico (Eds), Experimental and Comparative Toxicology, Vol. 31 of Advances in Veterinary Science and Comparative Medicine, Academic Press, Orlando, FL, pp. 95-119.
8. DeWaal, E.J., Timmerman, H.H., Dortant, P.M., Kranjc, M.A. and VanLoveren, H. (1995) Investigation of a screening battery for immunotoxicity of pharmaceuticals within a 28-day oral toxicity study using azathioprine and cyclosporin A as model compounds. Regul. Toxicol. Pharmacol. 21, 327-338.
9. Donatsch, P. and Ryffel, B. (1986) Pharmacokinetics of cyclosporine in toxicological studies. Transplant. Proc. 18, 71-76.
10. Finco, D.R. (1989) Kidney function. In: J.J. Kaneko (Ed), Clinical Biochemistry of Domestic Animals, 4th Ed, Academic Press, San Diego, pp. 496-542.
11. Houben, G.F., Penninks, A.H., Seinen, W., Vos, J.G. and Van Loveren, H. (1993) Immunotoxic effects of the color additive caramel color III: immune function studies in rats. Fundam. Appl. Toxicol. 20, 30-37.
12. Kimbrough, R.D. (1987) Human health effects of polychlorinated biphenyls (PCBs) and polybrominated biphenyls (PBBs). Ann. Rev. Pharmacol. Toxicol. 27, 87-111.
13. Liu J. (1993) FK506 and ciclosporin: molecular probes for studying intracellular signal transduction. Trends Pharm. Sci. 14, 182-188.
14. Luster, M.I., Munson, A.E., Thomas, P.T., Holsapple, M.P., Fenters, J.D., White, K.L., Lauer, L.D., Germolec, D.R., Rosenthal, G.J. and Dean, J.H. (1988) Development of a testing battery to assess chemical-induced immunotoxicity: National Toxicology Program's guidelines for immunotoxicity evaluation in mice. Fundam. Appl. Toxicol. 10, 2-19.
15. Luster, M.I., Portier, C., Pait, D.G., White, K.L., Gennings, C., Munson, A.E. and Rosenthal, G.J. (1992) Risk assessment in immunotoxicity. I. Sensitivity and predictability of immune tests. Fundam. Appl. Toxicol. 18, 200-210.
16. Lü, Y.C. and Wu, Y.C. (1985) Clinical findings and immunological abnormalities in Yu-Cheng patients. Environ. Health Perspect. 59, 17-29.
17. McFadden, R.G. (1988) The nylon wool adherence of rat mononuclear cells: physical, chemical and biological influences. J. Clin. Lab. Immunol. 26, 201-208.
18. Organization for Economic Cooperation and Development (1994) OECD Guideline for the Testing of Chemicals, Guideline 407. Document approved by the 22nd Joint Meeting, Paris, France.
19. Ryffel, B., Donatsch, P., Madrin, M., Matter, B.E., Rüttimann, G., Schn, H., Stoll, R. and Wilson, J. (1983) Toxicological evaluation of cyclosporin A. Arch. Toxicol. 53, 107-141.
20. Schuurman, H.J., Krajnc-Franken, M.A.M., Kuper, C.F., Van Loveren, H. and Vos, J.G. (1991) Immune system. In: W.M. Haschek and C.G. Rousseaux (Eds), Handbook of Toxicologic Pathology, Academic Press, San Diego, pp. 421-487.
21. Schuurman, H.J., VanLoveren, H., Rosing, J., VanDijk, A., Loeber, J.G. and Vos, J.G. (1990) Cyclosporin and the rat thymus. An immunohistochemical study. Thymus 16, 235-254.
22. Uhteg, L.C., Kupiec-Weglinski, J.W., Rocher, L.L., Salomon, D.R., Tilney, N.L. and Carpentier, C.B. (1986) Systemic natural killer activity following cardiac engraftment in the rat: lack of correlation with graft survival. Cell. Immunol. 100, 274-279.
23. US Food and Drug Administration, Center for Food Safety and Applied Nutrition (1993) Immunotoxicity studies. In: Draft Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, Redbook II, pp. 157-175.