Principles for the selection of doses in chronic rodent bioassays

J. A. Foran, W. T. Allaben, J. Ashby, R. Bass, J. R. Bucher, W. Burnam, J. S. Bus, B. E. Butterworth, M. Carakostas, J. Emerson, R. A. Cardona, S. M. Cohen, J. DeGeorge, P. Fenner-Crisp, J. A. Foran, D. Gaylor, J. F. Gee, J. I. Goodman, D. L. Grant, D. G. HattanY. Hayashi, R. F. Henderson, J. L. Herrman, H. B.W.M. Koeter, R. A. LeBoeuf, B. Domeyer, R. J. Lorentzen, E. E. McConnell, K. Mitsumori, S. S. Olin, J. C. Parker, A. Renwick, J. T. Stevens, J. A. Swenberg, A. S. Taylor, M. Van Gemert, V. Vu, R. Walker, M. Watson, K. L. Yielding

Research output: Contribution to journalShort survey

15 Citations (Scopus)

Abstract

Dose selection in chronic rodent bioassays has been one of the most debated issues in risk assessment. The Committee on Risk Assessment Methods of the National Research Council attempted, but failed, in 1993 to reach consensus on how to select doses for chronic rodent bioassays. However, a more recent effort conducted by the ILSI Risk Science Institute has resulted in a consensus set of principles for dose selection, including selection of the highest dose for chronic rodent bioassays. The principles encourage a move away from sole reliance on a maximum tolerated dose (MTD), as it has been traditionally defined (primarily by body weight and histopathology), and toward the use of sound scientific and toxicologic principles for the selection of all doses in the chronic bioassay. Specifically, the principles recommend that dose selection for chronic studies must be based on sound toxicologic principles; dose selection should consider human exposure; dose selection should be based on a variety of endpoints and effects derived from prechronic studies; and dose selection should consider physicochemical and other factors. Implementation of the principles internationally will have two important benefits: improvement in the quality and consistency of the rodent bioassay and international harmonization of dose selection procedures.

Original languageEnglish (US)
Pages (from-to)18-20
Number of pages3
JournalEnvironmental Health Perspectives
Volume105
Issue number1
DOIs
StatePublished - Jan 1 1997

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Bioassay
Biological Assay
rodent
bioassay
Rodentia
Risk assessment
Acoustic waves
Maximum Tolerated Dose
Quality Improvement
Body Weight
risk assessment
dose
histopathology
assessment method

Keywords

  • Chronic rodent bioassays
  • Dose selection
  • Principles

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health, Toxicology and Mutagenesis

Cite this

Foran, J. A., Allaben, W. T., Ashby, J., Bass, R., Bucher, J. R., Burnam, W., ... Yielding, K. L. (1997). Principles for the selection of doses in chronic rodent bioassays. Environmental Health Perspectives, 105(1), 18-20. https://doi.org/10.2307/3433048

Principles for the selection of doses in chronic rodent bioassays. / Foran, J. A.; Allaben, W. T.; Ashby, J.; Bass, R.; Bucher, J. R.; Burnam, W.; Bus, J. S.; Butterworth, B. E.; Carakostas, M.; Emerson, J.; Cardona, R. A.; Cohen, S. M.; DeGeorge, J.; Fenner-Crisp, P.; Foran, J. A.; Gaylor, D.; Gee, J. F.; Goodman, J. I.; Grant, D. L.; Hattan, D. G.; Hayashi, Y.; Henderson, R. F.; Herrman, J. L.; Koeter, H. B.W.M.; LeBoeuf, R. A.; Domeyer, B.; Lorentzen, R. J.; McConnell, E. E.; Mitsumori, K.; Olin, S. S.; Parker, J. C.; Renwick, A.; Stevens, J. T.; Swenberg, J. A.; Taylor, A. S.; Van Gemert, M.; Vu, V.; Walker, R.; Watson, M.; Yielding, K. L.

In: Environmental Health Perspectives, Vol. 105, No. 1, 01.01.1997, p. 18-20.

Research output: Contribution to journalShort survey

Foran, JA, Allaben, WT, Ashby, J, Bass, R, Bucher, JR, Burnam, W, Bus, JS, Butterworth, BE, Carakostas, M, Emerson, J, Cardona, RA, Cohen, SM, DeGeorge, J, Fenner-Crisp, P, Foran, JA, Gaylor, D, Gee, JF, Goodman, JI, Grant, DL, Hattan, DG, Hayashi, Y, Henderson, RF, Herrman, JL, Koeter, HBWM, LeBoeuf, RA, Domeyer, B, Lorentzen, RJ, McConnell, EE, Mitsumori, K, Olin, SS, Parker, JC, Renwick, A, Stevens, JT, Swenberg, JA, Taylor, AS, Van Gemert, M, Vu, V, Walker, R, Watson, M & Yielding, KL 1997, 'Principles for the selection of doses in chronic rodent bioassays', Environmental Health Perspectives, vol. 105, no. 1, pp. 18-20. https://doi.org/10.2307/3433048
Foran JA, Allaben WT, Ashby J, Bass R, Bucher JR, Burnam W et al. Principles for the selection of doses in chronic rodent bioassays. Environmental Health Perspectives. 1997 Jan 1;105(1):18-20. https://doi.org/10.2307/3433048
Foran, J. A. ; Allaben, W. T. ; Ashby, J. ; Bass, R. ; Bucher, J. R. ; Burnam, W. ; Bus, J. S. ; Butterworth, B. E. ; Carakostas, M. ; Emerson, J. ; Cardona, R. A. ; Cohen, S. M. ; DeGeorge, J. ; Fenner-Crisp, P. ; Foran, J. A. ; Gaylor, D. ; Gee, J. F. ; Goodman, J. I. ; Grant, D. L. ; Hattan, D. G. ; Hayashi, Y. ; Henderson, R. F. ; Herrman, J. L. ; Koeter, H. B.W.M. ; LeBoeuf, R. A. ; Domeyer, B. ; Lorentzen, R. J. ; McConnell, E. E. ; Mitsumori, K. ; Olin, S. S. ; Parker, J. C. ; Renwick, A. ; Stevens, J. T. ; Swenberg, J. A. ; Taylor, A. S. ; Van Gemert, M. ; Vu, V. ; Walker, R. ; Watson, M. ; Yielding, K. L. / Principles for the selection of doses in chronic rodent bioassays. In: Environmental Health Perspectives. 1997 ; Vol. 105, No. 1. pp. 18-20.
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AU - Burnam, W.

AU - Bus, J. S.

AU - Butterworth, B. E.

AU - Carakostas, M.

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AU - Hayashi, Y.

AU - Henderson, R. F.

AU - Herrman, J. L.

AU - Koeter, H. B.W.M.

AU - LeBoeuf, R. A.

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AU - Stevens, J. T.

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