Reference Data of the Main Physiological Parameters in Control Sprague-Dawley Rats from Pre-clinical Toxicity Studies

  • Received : 2010.02.16
  • Accepted : 2010.06.10
  • Published : 2010.06.30

Abstract

The purpose of this paper is to provide reference data related to the body weight, food & water consumptions, urinalysis, hematology and serum biochemistry parameters and absolute & relative organ weights obtained from control Sprague-Dawley rats, used in the 4-week and 13-week repeated-dose toxicity studies conducted in our laboratory between 2005 and 2008. The mean, standard deviation, minimum and maximum range values for hematology and serum biochemistry parameters, data of absolute & relative organ weights, and the difference between sexes and study duration of week 4 versus 13 week are presented. The studies were conducted according to "the standards of Toxicity Study for Medicinal Products" (2005) and The KFDA Notification No. 2000-63 'Good Laboratory Practice (GLP)' (2000) issued by KFDA. These data could be used as reference material of Sprague-Dawley rats by conducting the studies to evaluate the toxicological profile of pre-clinical toxicity studies.

Keywords

References

  1. Abrass, C.K. (2000) The nature of chronic progressive nephropathy in aging rats. Adv. Ren. Replace. Ther. 7(1), 4-10. https://doi.org/10.1016/S1073-4449(00)70001-X
  2. Aleman, C.L., Mas, R.M., Rodeiro, I., Noa, M., Hernandez, C., Mendndez, R. and Gamez, R. (1998) Reference database of the main physiological parameters in Sprague Dawley rats from 6 to 32 months. Lab. Anim. 32(4), 457-66. https://doi.org/10.1258/002367798780599802
  3. Aleman, C.L., Noa, M., Mas, R., Rodeiro, I., Mesa, R., Mendndez, R., Gamez, R. and Hernandez, C. (2000) Reference data for the principal physiological indicators in three species of laboratory animals. Lab. Anim. 34(4), 379- 385. https://doi.org/10.1258/002367700780387741
  4. Alt, J.M., Deerberg, F., Hackbarth, H.J. and Stolte, H. (1980) The study of urinary protein excretion in male rats as compared with human proteinuria. Contrib. Nephrol. 19, 1979-1987.
  5. Ando, R., Nakamura, A., Nagatani, M., Yamakawa, S., Ohira, T., Takagi, M., Matsushima, K., Aoki, A., Fujita, Y. and Tamura, K. (2008) Comparison of Past and Recent Historical Control Data in Relation to Spontaneous Tumors During Carcinogenicity Testing in Fischer 344 Rats. J. Toxicol. Pathol. 21, 53-60. https://doi.org/10.1293/tox.21.53
  6. Bauck, L. and Stefkovic, G. (1986) Searching the records for clues about kidney disease in guineapigs. Vet. Med. 81, 1127–1130.
  7. Baylis, C. (2005) Changes in renal hemodynamics and structure in the aging kidney; sexual dimorphism and the nitric oxide system. Exp. Gerontol. 40(4), 271–278. https://doi.org/10.1016/j.exger.2005.01.008
  8. Bolton, W.K., Benton, F.R., Maclay, J.G. and Sturgill, B.C. (1976) Spontaneous glomerular sclerosis in aging Sprague-Dawley rats. I. Lesions associated with mesangial IgM deposits. Am. J. Pathol. 85(2), 277-302.
  9. Bounous, D., Bourdeaux, M.K. and Hoskins, J.D. (1995) Hematology of normal dogs and cats and responses to diseases. pp. 337-353, WB Saunders Co, Philadelphia.
  10. Braun, J.P., Aktas, M., Lefebvre, H., Rico, A.G. and Toutain, P.L. (1993) Clinical enzymology for the assessment of organ damage: interspecific differences. Comp. Haematol. Int. 3, 27-32. https://doi.org/10.1007/BF00394924
  11. Dodds, W.J. (1980) Hemostasis and coagulation. pp. 671-718, Academic Press, New York.
  12. Elcuman, E.A. and Akay, M.T. (1998) Age-Dependent Immunolocalization of Fibronectin and Histological Changes in the Thymus of Rats. Vet. Res. Comm. 22(8), 525-532. https://doi.org/10.1023/A:1006141719909
  13. Elmore, S.A. (2006) Enhanced Histopathology of the Thymus. Toxicol. Pathol. 34(5), 656-665. https://doi.org/10.1080/01926230600865556
  14. Gonder, J.C. and Laber, K. (2007) A renewed look at laboratory rodent housing and management. ILAR J. 48(1), 29-36. https://doi.org/10.1093/ilar.48.1.29
  15. Iwata, H., Hagiwara, T., Katoh, M., Yamamoto, S., Yamakawa, S., Shiga, A., Hirouchi, Y., Kobayashi, K., Inoue, H. and Enomoto, M. (1993) Historical control data of organ weight and gross findings in F344/DuCrj rats and B6C3F1 mice. Jikken Dobutsu 42(3), 383-396.
  16. Kaneko, J.J. (1997) Serum proteins and the dysproteinemias. pp. 117–138, Academic Press, London, New York.
  17. Kang, B.H., Kim, Y.B., Lee, H.S., Kim, Y.H., Im, W.J. and Ha, H.S. (2004) Background Data on Hematology, Blood Biochemistry and Organ Weights for 2 Weeks and 4 Weeks Repeated-Dose Toxicity Studies Using Sprague-Dawley (SD) Rats. Korean J. of Lab. Anim. Sci. 20(2), 134-140.
  18. Kang, B.H., Son, H.Y. Ha, C.S., Lee, H.S. and Song, S.W. (1995) Reference values of hematology and serum chemistry in Ktc: Sprague-Dawley rats. Korean J. of Lab. Anim. Sci. 11(2), 141- 145.
  19. Kitagaki, M., Yamaguchi, M., Nakamura, M., Sakurada, K., Suwa, T. and Sasa, H. (2005) Age-related changes in haematology and serum chemistry of Weiser-Maples guineapigs (Cavia porcellus). Lab. Anim. 39(3), 321-330. https://doi.org/10.1258/0023677054307042
  20. Kohn, D.F. and Clifford, C.B. (2002) Laboratory animal medicine. pp. 121-165, Academic Press, Amsterdam.
  21. Leonard, R. and Ruben, Z. (1986) Hematology reference values for peripheral blood of laboratory rats. Lab. Anim. Sci. 36(3), 277-281.
  22. Lipman, N.S. and Perkins, S.E. (2002) Laboratory animal medicine, pp. 1143-1184, Academic Press, Amsterdam.
  23. Loeb, W.F. and Carakostas, M.C. (1992) Pathobiology of the Aging Rat. pp. 7-13, ILSI Press, Washington.
  24. Loeb, W.F., Das, S.R., Harbour, L.S., Turturro, A., Bucci, T.J. and Clifford, C.B. (1996) Pathobiology of the Aging Mouse. pp. 3- 20, ILSI Press, Washington.
  25. Loria, A., Reverte, V., Salazar, F., Saez, F., Llinas, M.T. and Salazar, F.J. (2007) Sex and age differences of renal function in rats with reduced Ang II activity during the nephrogenic period. Am. J. Physiol. Renal. Physiol. 293(2), 506-510. https://doi.org/10.1152/ajprenal.00066.2007
  26. Matsuzawa, T., Nomura, M., Yonezawa, H. and Unno, T. (1995) Selection of appropriate parameters, use of a quality control concept, and suitable statistical analyses for clinical pathology examination of animals in toxicity studies: results of a current survey by the Japanese Pharmaceutical Manufacturers Association. Comp. Haematol. Int. 5, 196-200. https://doi.org/10.1007/BF00368044
  27. Owen, R.A. and Haywood, R. (1986) Age-related variations in renal structure and function in Sprague-Dawley rats. Toxicol. Pathol. 14, 158-167. https://doi.org/10.1177/019262338601400203
  28. Petterino, C. and Argentino-Storino, A. (2006) Clinical chemistry and haematology historical data in control Sprague-Dawley rats from pre-clinical toxicity studies. Exp. Toxicol. Pathol. 57(3), 213-219. https://doi.org/10.1016/j.etp.2005.10.002
  29. Ragan, H.A. and Weller, R.E. (1999) The Clinical Chemistry of Laboratory Animals, 2nd ed., pp. 519-548, Taylor & Francis Inc, Philadelphia.
  30. Roe, F.J.C. (1991) Biological Effects of Dietary Restriction. pp 287-304, Springer-Verlag, Berlin.
  31. Roe, F.J.C. (1993) Experimental Toxicology. pp. 28, Surrey, Bibra.
  32. Sauer, M.B., Dulac, H., Clark, S., Moffitt, K.M., Price, J., Dambach, D., Mosher, H., Bounous, D. and Keller, L. (2006) Clinical pathology laboratory values of rats housed in wirebottom cages compared with those of rats housed in solidbottom cages. J. Am. Assoc. Lab. Anim. Sci. 45(1), 30-35.
  33. Seki. M., Hirashima K., Kobayashi K. (1981) Hematology of experimental animals. pp. 334-335, Soft Science, Inc., Tokyo.
  34. Sharp, J., Zammit, T., Azar, T., Lawson, D. (2003) Stress-like responses to common procedures in individually and grouphoused female rats. Contemp. Top. Lab. Anim. Sci. 42(1), 9- 18.
  35. Snell, K.C. (1967) Pathology of laboratory rats and mice. pp. 104-145, Blackwell, Oxford.
  36. Song, C.W., Hwang, H.S. and Han, S.S. (1990) Studies on the Basic data of Ktc:SD Rats with Age-Body weight, Hematology, Serum Chemistry and Urinalysis. Korean J. of Lab. Anim. Sci. 6(1), 33-43.
  37. Song, C.W., Hwang, H.S. and Han, S.S. (1992) Studies on the Basic data of Ktc:Wistar Rats with Age-Body weight, Organ Weight, Hematology, Serum Chemistry and Urinalysis. Korean J. of Lab. Anim. Sci. 8(1), 13-22.
  38. Stevens, K.R. and Gallo, M.A. (1989) Principles and Methods of Toxicology. 3rd ed., pp. 237-250. Raven Press, New York.
  39. Tanimoto, Y. (1988) Laboratory animals [in Japanese] pp. 91, Soft Science, Inc., Tokyo, Japan.
  40. Uchida, K., Chikai, T., Takase, H., Nomura, Y., Seo, S., Nakao, H., and Takeuchi, N. (1990) Age-Related Changes of Bile Acid Metabolism in Rats. Arch. Gerontol. Geriatr. 10(1), 37- 48. https://doi.org/10.1016/0167-4943(90)90042-5
  41. Verhagen, A.M., Attia, D.M., Koomans, H.A. and Joles, J.A. (2000) Male gender increases sensitivity to proteinuria induced by mild NOS inhibition in rats: role of sex hormones. Am. J. Physiol. Renal. Physiol. 279(4), 664-670. https://doi.org/10.1152/ajprenal.2000.279.4.F664
  42. Weingand, K.W., Bloom, J., Carakostas, M., Hall, R., Helfrich, M., Latimer, K., Levine, B., Neptun, D., Rebar, A., Stitzel, K. and Troup, C. (1992) Clinical pathology testing recommendations for nonclinical toxicity and safety studies. Toxicol. Pathol. 20, 539-543. https://doi.org/10.1177/019262339202000317
  43. Williams, G.M. and Weirburger, J.H. (1991) Chemical carcinogenesis. pp. 127-200, Pergamon Press, New York.
  44. Wolford, S.T., Schroer, R.A., Gohs, F.X., Gallo, P.P., Brodeck, M. Falk, H.B. and Ruhren, F.R. (1986) Reference range data base for serum chemistry and hematology values in laboratory animals. J. Toxicol. Environ. Health 18(2), 161-188. https://doi.org/10.1080/15287398609530859
  45. Wolford, S.T., Schorer, R.A., Gallo, P.P., Gohs, F.X., Brodeck, M., Falk, H.B. and Ruhren, R. (1987) Age-related changes in serum chemistry and hematology values in normal Sprague- Dawley rats. Fundam. Appl. Toxicol. 8(1), 80-88. https://doi.org/10.1016/0272-0590(87)90102-3
  46. Yamada, J. (1989) Biochemical Reference Data Book on Experimental Animals. Soft Science. Inc. Tokyo, Japan.