Methods for identifying a default cross-species scaling factor

Human and Ecological Risk Assessment

Volumn 12, Issue 6, 2006, Pages 1094-1127

  Rhomberg, Lorenz R ^a   Lewandowski, Thomas A ^a  

^a GRADIENT   (United States)

Author keywords

Allometry; Cross species; Dose extrapolation; Dosimetry; Risk assessment

Indexed keywords

ANIMALIA;

EID: 33750424021     PISSN: 10807039     EISSN: 15497860     Source Type: Journal    
DOI: 10.1080/10807030600977269     Document Type: Review

References (105)

1. Adolph EF. 1949. Quantitative relations in the physiological constitution of mammals. Science 109:579-85
2. Andersen ME and Krishnan K. 1994. Physiologically based pharmacokinetics and cancer risk assessment. Environ Health Perspect 102(Suppl. 1):103-8
3. Andersen ME, Clewell H III, and Krishnan K. 1995. Tissue dosimetry, pharmacokinetic modeling, and interspecies scaling factors. Risk Anal 15:533-7
4. Baird SJS, Cohen JT, Graham JD, et al. 1996. Noncancer risk assessment: A probabilistic alternative to current practice. Hum Ecol Risk Assess 2:79-102
5. Beliles RP and Parker JC. 1989. Dose paradigms for inhaled vapors of primary carcinogens and their impact on risk assessment. Health Phys 57(Suppl. 1):333-40
6. Bogdanffy MS and Jarabek AM. 1995. Understanding mechanisms of inhaled toxicants: implications for replacing default factors with chemical-specific data. Toxicol Lett 82-83:919-32
7. Bogdanffy MS, Sarangapani R, Plowchalk DR, et al. 1999. A biologically based risk assessment for vinyl acetate-induced cancer and noncancer inhalation toxicity. Toxicol Sci 51:19-35
8. Bogdanffy MS, Daston G, Faustman EM, et al. 2001. Harmonization of cancer and noncancer risk assessment: Proceedings of a consensus-building workshop. Toxicol Sci 61:18-31
9. Boxenbaum H. 1982. Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics. J Pharmacol Biopharm 10:201-27
10. Boxenbaum H. 1983. Evolutionary biology, animal behavior, fourth-dimensional space, and the raison d'etre of drug metabolism and pharmacokinetics. Drug Metab Rev 14:1057-97
11. Boxenbaum H. 1984. Interspecies pharmacokinetic scaling and the evolutionary-comparative paradigm. Drug Metab Rev 15:1071-121
12. Boxenbaum H. 1986. Time concepts in physics, biology, and pharmacokinetics. J Pharmacol Sci 75:1053-62
13. Boxenbaum H and R Ronfeld. 1983. Interspecies pharmacokinetic scaling and the Dedrick plots. Am J Physiol 245:R768-75
14. Bruckner JV. 2000. Differences in sensitivity of children and adults to chemical toxicity: The NAS panel report. Regul Toxicol Pharmacol 31:280-5
15. Butterworth BE and Bogdanffy MS. 1999. A comprehensive approach for integration of toxicity and cancer risk assessments. Regul Toxicol Pharmacol 29:23-36
16. Calabrese EJ. 1983. Principles of Animal Extrapolation. John Wiley & Sons, New York, NY, USA
17. Calabrese EJ. 1986a. Animal extrapolation and the challenge of human heterogeneity. J Pharmacol Sci 75:1041-6
18. Calabrese EJ. 1986b. Comparative biology of test species. In: Hill TA,Wands RC, and Leukroth RW Jr. (eds), Biological Bases for Interspecies Extrapolation of Carcinogenicity Data. Prepared under contract to Federation of American Societies for Experimental Biology, FDA contract No 223-83-2020 for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services, Washington, DC, USA
19. Calabrese EJ. 1987. Extrapolation from animal data. In: Tardiff RG and Rodricks JV (eds), Toxic Substances and Human Risk: Principles of Data Interpretation. Plenum Press, New York, NY, USA
20. Casanova M, Morgan KT, Steinhagen WH, et al. 1991. Covalent binding of inhaled formaldehyde toDNAin the respiratory tract of rhesus monkey: pharmacokinetics, rat-to-monkey interspecies scaling, and extrapolation to man. Fundam Appl Toxicol 17:409-28
21. Clewell HJ, Andersen ME, and Barton HA. 2002a. A consistent approach for the application of pharmacokinetic modeling in cancer and noncancer risk assessment. Environ Health Perspect 110:85-93
22. Clewell HJ, Teeguarden J, McDonald T, et al. 2002b. Review and evaluation of the potential impact of age- and gender-specific pharmacokinetic differences on tissue dosimetry. Crit Rev Toxicol 32:329-89
23. Collins JM, Grieshaber CK, and Chabner BA. 1986. Potential role for preclinical pharmacology in phase I clinical trials. Cancer Treat Rep 70:73-80
24. Collins JM, Zaharko DS, Dedrick RL, et al. 1990. Pharmacologically guided phase I clinical trials based upon preclinical drug development. J Natl Cancer Inst 82:1321-6
25. Conolly RB. 1995. Cancer and non-cancer risk assessment: Not so different if you consider mechanisms. Toxicology 102:179-88
26. Conolly RB and Andersen ME. 1993. An approach to mechanism-based cancer risk assessment for formaldehyde. Environ Health Perspect 101:169-76
27. Conolly RB, Lilly PD, and Kimbell, JS. 2000. Simulation modeling of the tissue disposition of formaldehyde to predict nasal DNA-protein cross-links in Fischer 344 rats, rhesus monkeys, and humans. Environ Health Perspect 108(Suppl. 5):919-24
28. Conolly RB, Kimbell JS, Janszen DB, et al. 2002. Dose response for formaldehyde-induced cytotoxicity in the human respiratory tract. Regul Toxicol Pharmacol 35:32-43
29. Cox LA Jr and Ricci PF. 1992. Reassessing benzene cancer risks using internal doses. Risk Anal 12:401-10
30. Crump K, Allen B, and Shipp A. 1989. Choice of dose measure for extrapolating carcinogenic risk from animals to humans: An empirical investigation of 23 chemicals. Health Physics 57(Suppl. 1):387-93
31. Crump KS, Silvers A, Ricci PF, et al. 1985. Interspecies comparison for carcinogenic potency to humans. In: Ricci PF (ed), Principles of Health Risk Assessment. Prentice-Hall, Englewood Cliffs, NJ, USA
32. Dahl AR, Sun JD, Birnbaum LS, et al. 1991. Toxicokinetics of inhaled 1,3-butadiene in monkeys: Comparison to toxicokinetics in rats and mice. Toxicol Appl Pharmacol 110:9-19
33. Davidson IWF, Parker JC, and Beliles RP. 1986. Biological basis for extrapolation across mammalian species. Reg Toxicol Pharmacol 6:211-37
34. Dedrick RL. 1973. Animal scale-up. J Pharma Biopharm 1:435-61
35. Dedrick RO, Bischoff KB, and Zaharko DS. 1970. Interspecies correlation of plasma concentration history of methotrexate (NSC-740). Cancer Chemother Rep Pt 1, 54:95-101
36. Dorne JL, Walton K, and Renwick AG. 2001. Uncertainty factors for chemical risk assessment. Human variability in the pharmacokinetics of CYP1A2 probe substrates. Food Chem Toxicol 39:681-96
37. Dourson M. 1996. Uncertainty factors in noncancer risk assessment. Regul Toxicol Pharmacol 24(2 Pt 1):107
38. Dourson ML and Stara JF. 1983. Regulatory history and experimental support of uncertainty (safety) factors. Regul Toxicol Pharmacol 3:224-38
39. Dourson ML, Felter SP, and Robinson D. 1996. Evolution of science-based uncertainty factors in noncancer risk assessment. Regul Toxicol Pharmacol 24(2 Pt 1):108-20
40. Dourson ML, Knauf LA, and Swartout JC. 1992. On reference dose (RfD) and its underlying toxicity data base. Toxicol Ind Health 8:171-89
41. Evans JS, Rhomberg LR, Williams PL, et al. 2001. Reproductive and developmental risks from ethylene oxide: A probabilistic characterization of possible regulatory thresholds. Risk Anal 21:697-717
42. Fredrick CB, Gentry PR, Bush ML, et al. 2001. A hybrid computational fluid dynamics and physiologically based pharmacokinetic model for comparison of predicted tissue concentrations of acrylic acid and other vapors in the rat and human nasal cavities following inhalation exposure. Inhal Toxicol 13:359-76
43. Fredrick CB, Lomax LG, Black KA, et al. 2002. Use of a hybrid computational fluid dynamics and physiologically based inhalation model for interspecies dosimetry comparisons of ester vapors. Toxicol Appl Pharmacol 183:23-40
44. Freireich EJ, Gehan EA, Rall DP, et al. 1966. Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey and man. Cancer Chemother Rep 50:219-44
45. Gaylor DW and Kodell RL. 1999. Dose-response trend tests for tumorigenesis, adjusted for body weight. Toxicol Sci 49:318-23
46. Gentry PR, Covington TR, and Clewell HJ III. 2003. Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation. Regul Toxicol Pharmacol 38:1-16
47. Gillette JR. 1987. Dose, species and route extrapolation: General aspects. In: National Research Council. Pharmacokinetics in Risk Assessment: Drinking Water and Health, vol. 8. National Academy Press, Washington, DC, USA
48. Ginsberg G, Hattis D, Sonawane B, et al. 2002. Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci 66:185-200
49. Ginsberg G, Hattis D, Russ A, et al. 2004. Physiologically based pharmacokinetic (PBPK) modeling of caffeine and theophylline in neonates and adults: Implications for assessing children's risks from environmental agents. J Toxicol Environ Health A 67:297-329
50. Goldman LR. 1995. Children-unique and vulnerable. Environmental risks facing children and recommendations for response. Environ Health Perspect 103(Suppl. 6):13-18
51. Goldman LR. 1998. Linking research and policy to ensure children's environmental health. Environ Health Perspect 106(Suppl. 3):857-62
52. Goldman LR and Koduru S. 2000. Chemicals in the environment and developmental toxicity to children: A public health and policy perspective. Environ Health Perspect 108(Suppl. 3):443-8
53. Hart RW and Setlow RB. 1974. Correlation between deoxyribonucleic acid excision-repair and life-span in a number of mammalian species. Proc Natl Acad Sci USA 71:2169-73
54. Hattis D. 1991. Use of biological markers and pharmacokinetics in human health risk assessment. Environ Health Perspect 89:230-8
55. Hattis D, Ginsberg G, Sonawane B, et al. 2003. Differences in pharmacokinetics between children and adults-II. Children's variability in drug elimination half-lives and in some parameters needed for physiologically-based pharmacokinetic modeling. Risk Anal 23:117-42
56. Hill TA, Wands RC, and Leukroth RW Jr (eds). 1986. Biological Bases for Interspecies Extrapolation of Carcinogenicity Data. Prepared under contract to Federation of American Societies for Experimental Biology, FDA contract No 223-83-2020 for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services, Washington, DC, USA
57. Hoel DG. 1977. Some problems in low-dose extrapolation. In: Hiatt HH, Watson JD, and Winsten JA (eds), Origins of Human Cancer: Book C, Human Risk Assessment. Cold Spring Harbor Conferences on Cell Proliferation, vol. 4, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY, USA
58. Hogan M and DG Hoel. 1982. Extrapolation to man. In: Hayes, AW (ed), Principles of Toxicology, 771-31. Raven Press, New York, NY, USA
59. Ings RM. 1990. Interspecies scaling and comparisons in drug development and toxicokinetics. Xenobiotica 20:1201-31
60. Jarabek AM. 1995. Interspecies extrapolation based on mechanistic determinants of chemical disposition. Hum Ecol Risk Assess 1:641-62
61. Jarabek AM, Menache MG, Overton JH, et al. 1989. Inhalation reference dose (RfDi): An application of interspecies dosimetry modeling for risk assessment of insoluble particles. Health Phys 57(Supp 1):177-83
62. Kalberlah F, Fost U, and Schneider K. 2002. Time extrapolation and interspecies extrapolation for locally acting substances in case of limited toxicological data. Ann Occup Hyg 46:175-85
63. Kleiber M. 1932. Body size and metabolism. Hilgardia 6:315-53
64. Kuo J, Linkov I, Rhomberg L, et al. 2002. Absolute risk or relative risk? A study of intraspecies and interspecies extrapolation of chemical-induced cancer risk. Risk Anal 22:141-57
65. Landrigan PJ. 1999. Risk assessment for children and other sensitive populations. Ann NY Acad Sci 895:1-9
66. Lindstedt SL. 1987. Allometry: Body size constraints in animal design. In: Pharmacokinetics in Risk Assessment: Drinking Water and Health, vol. 8. National Research Council, National Academy Press, Washington, DC, USA
67. Lindstedt SL and Calder WA. 1976. Body size and longevity in birds. Condor 78:91-4
68. Lindstedt SL and Calder WA. 1981. Body size, physiological time, and longevity of homeothermic animals. Quart Rev Biol 56:1-16
69. Mahmood I. 1999. Allometric issues in drug development. J Pharm Sci 88:1101-6
70. Mantel N and Schneiderman MA. 1975. Estimating safe levels, a hazardous undertaking. Cancer Res 35:1379-86
71. Meek B, Renwick A, and Sonich-Mullin C. 2003. Practical application of kinetic data in risk assessment-an IPCS initiative. Toxicol Lett 138:151-60
72. Miller MD, Marty MA, Arcus A, et al. 2002. Differences between children and adults: Implications for risk assessment at California EPA. Int J Toxicol 21:403-18
73. Miller RP, Roberts RJ, and Fischer, LJ. 1976. Acetaminophen elimination kinetics in neonates, children, and adults. Clin Pharmacol Ther 19:284-94
74. Monticello TM and Morgan, KT. 1994. Cell proliferation and formaldehyde-induced respiratory carcinogenesis. Risk Anal 14:313-9
75. Mordenti J. 1986. Man versus beast: Pharmacokinetic scaling in mammals. J Pharmacol Sci 75:1028-40
76. Morgan KT. 1997. A brief review of formaldehyde carcinogenesis in relation to rat nasal pathology and human health risk assessment. Toxicol Pathol 25:291-307
77. O'Flaherty EJ. 1989. Interspecies conversion of kinetically equivalent doses. Risk Anal 9:587-98
78. O'Flaherty EJ. 1994. Physiologic changes during growth and development. Environ Health Perspect 102(Suppl 11):103-6
79. Pauluhn J. 2003. Issues of dosimetry in inhalation toxicity. Toxicol Lett 140-141:229-38
80. Pelekis M, Gephart LA, and Lerman SE. 2001. Physiological-model-based derivation of the adult and child pharmacokinetic intraspecies uncertainty factors for volatile organic compounds. Regul Toxicol Pharmacol 33:12-20
81. Pinkel D. 1958. The use of body surface area as a criterion of drug dosage in cancer chemotherapy. Cancer Res 18:853-6
82. Rall DP. 1977. Species differences in carcinogenesis testing. In: Hiatt HH, Watson JD, and Winsten JA (eds), Origins of Human Cancer: Book C, Human Risk Assessment. Cold Spring Harbor Conferences on Cell Proliferation, vol. 4. Cold Spring Harbor Laboratory, Cold Spring Harbor, NY, USA
83. Reitz RH, Mendrala AL, and Guengerich FP. 1988. In vitro studies of methylene chloride (MEC) metabolism in human and animal tissues: Use in physiologically-based pharmacokinetic (PB-PK) models. Toxicologist 8:156
84. Renwick AG. 1998. Toxicokinetics in infants and children in relation to the ADI and TDI. Food Addit Contam 15(Suppl):17-35
85. Renwick AG, Dorne JL, and Walton K. 2000. An analysis of the need for an additional uncertainty factor for infants and children. Regul Toxicol Pharmacol 31:286-96
86. Rhomberg LR. 1994. Empirical comparisons of carcinogen potencies across species and their bearing on appropriate scaling of doses for risk assessment. In: Wang RGM (ed), Water Contamination and Health: Integration of Exposure Assessment, Toxicology, and Risk Assessment, p. 425-445. Marcel Dekker, Inc., New York, NY, USA
87. Rhomberg LR. 1995. Use of quantitative modelling in methylene chloride risk assessment. Toxicology 102:95-114
88. Rhomberg LR. 2000. Mode of action as a guide to quantitative analytical approaches. Presented at the Society of Toxicology Annual Meeting, Philadelphia, PA, USA, March 21
89. Rhomberg LR. 2002. Dose scaling and extrapolation across age groups. Human Ecol Risk Assess 8:783-803
90. Rhomberg LR and Caprario LC. 1999. Cross-species and cross-route comparisons of acute lethal doses: Further results of analysis of a large database. In: Society for Risk Analysis Annual Meeting, Atlanta, GA, USA. December 6
91. Rhomberg LR and Wolff SK. 1998. Empirical scaling of single oral lethal doses across mammalian species based on a large database. Risk Anal 18:741-53
92. Riviere JE, Martin-Jimenez T, Sundlof SF, et al. 1997. Interspecies allometric analysis of the comparative pharmacokinetics of 44 drugs across veterinary and laboratory animal species. J Vet Pharmacol Ther 20:453-63
93. Sarangapani R, Gentry PR, Covington TR, et al. 2003. Evaluation of the potential impact of age- and gender-specific lung morphology and ventilation rate on the dosimetry of vapors. Inhal Toxicol 15:987-1016
94. Schein PS, Davis RD, Carter S, et al. 1979. The evaluation of anticancer drugs in dogs, and monkeys for the predication of quantitative toxicities in man. Clin Pharmacol Therapeut 11:3-40
95. Schlosser PM, Lilly PD, Conolly RB, et al. 2003. Benchmark dose risk assessment for formaldehyde using airflow modeling and a single-compartment, DNA-protein cross-link dosimetry model to estimate human equivalent doses. Risk Anal 23:473-87
96. Schmidt CW, Gillis CA, Keenan RE, et al. 1997. Characterizing inter-chemical variation in the interspecies uncertainty factor (UFa). Fundam Appl Toxicol (Suppl) 36(1 Part 2):208. Abstract 1057
97. Starr TB. 1990. Quantitative cancer risk estimation for formaldehyde. Risk Anal 10:85-91
98. Travis CC. 1990. Tissue dosimetry for reactive metabolites. Risk Anal 10:317-21
99. Travis CC and Bowers JC. 1991. Interspecies scaling of anesthetic potency. Toxicol Ind Health 7:249-60
100. Travis CC and White RK. 1988. Interspecific scaling of toxicity data. Risk Anal 8:119-25
101. 3/4/day. Fed Reg 57(109):24152(22). June 5
102. USEPA. 1994. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. EPA/600/8-90/006F. Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office, Research Triangle Park, NC, USA
103. USEPA. 1999. Guidelines for Carcinogen Risk Assessment (Review Draft). NCEA-F-0644. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC, USA
104. Vocci F and Farber T. 1988. Extrapolation of animal toxicity data to man. Regul Toxicol Pharmacol 8:389-98
105. Watanabe KH and Bois FY. 1996. Interspecies extrapolation of physiological pharmacokinetic parameter distributions. Risk Anal 16:741-54