Toxicological evaluation and risk assessment of chemical mixtures

Critical Reviews in Toxicology

Volumn 28, Issue 1, 1998, Pages 73-101

  Cassee, Flemming R ^a,b   Groten, John P ^a   Van Bladeren, Peter J ^a   Feron, Victor J ^a  

^a TNO   (Netherlands)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Combination toxicology; Complex mixtures; Isoboles; Physiologically based toxicokinetic modeling; Response surface analysis; Simple mixtures; Weight of evidence approach

Indexed keywords

CHEMICAL COMPOUND;

CHEMICAL ANALYSIS; DOSE RESPONSE; DRUG MECHANISM; DRUG POTENTIATION; ENVIRONMENTAL EXPOSURE; REVIEW; RISK ASSESSMENT; TOXIN ANALYSIS;

ANIMALS; DRUG INTERACTIONS; DRUG SYNERGISM; GUIDELINES; INTERNATIONAL COOPERATION; MALE; MODELS, BIOLOGICAL; MODELS, STATISTICAL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RATS; RISK ASSESSMENT; XENOBIOTICS;

EID: 0031886290     PISSN: 10408444     EISSN: None     Source Type: Journal    
DOI: 10.1080/10408449891344164     Document Type: Review

References (85)

1. Krishnan, K. and Brodeur, J., Toxicological consequences of combined exposure to environmental pollutants, Arch. Complex Environ. Studies, 3, 1-104, 1991.
2. Yang, R. S. H., Introduction to the toxicology of chemical mixtures, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 1-10.
3. Calabrese, E. J., Multiple Chemical Interactions, Lewis Publishers, Chelsea, 1991, 704.
4. Mumtaz, M. M., Sipes, I. G., Clewell, H. J., and Yang, R. S. H., Risk assessment of chemical mixtures: biologic and toxicologic issues, Fund. Appl. Toxicol., 21, 258-269, 1993.
5. Feron, V. J., Jonker, D., van den Berg, M., Bogaards, J. J. P., Groten, J. P., and van Bladeren, P. J., Some principles of combination toxicology applied to defined mixtures of (chlorinated organic) chemicals, in: Proceedings of the Conference on Chlorinated Organic Chemicals: Their Effect on Human Health and the Environment, The Toxicology Forum, Berlin, 1994, 390-421.
6. Feron, V. J., Groten, J. P., Jonker, D., Cassee, F. R., and van Bladeren, P. J., Toxicology of chemical mixtures: challenges for today and the future, Toxicology, 105, 415-427, 1995.
7. Feron, V. J., Woutersen, R. A., Arts, J. H. E., Cassee, F. R., de Vrijer, FI., and van Bladeren, P. J., Safety evaluation of the mixture of chemicals at a specific workplace: theoretical considerations and a suggested two-step procedure, Toxicol. Lett., 76, 47-55, 1995.
8. Feron, V. J. and Bolt, H. M., Combination toxicology, Food Chem. Toxicol., 34, 1025-1185, 1996.
9. Yang, R. S. H., Toxicology of Chemical Mixtures, Academic Press, San Diego, 1994, 720.
10. Steel, G. G. and Peckham, M. J., Exploitable mechanisms in combined radiotherapy-chemotherapy, the concept of additivity, Int. J. Radiation Oncol. Biol. Phys., 5, 85-91, 1979.
11. Henschler, D., Bolt, H. M., Jonker, D., Pieters, M. N., and Groten, J. P., Experimental designs and risk assessment in combination toxicology: panel discussion, Food Chem. Toxicol., 34, 1183-1185, 1996.
12. Feron, V. J., van Bladeren, P. J., and Hermus, R. J. J., A view point on the extrapolation of toxicological data from animals to man, Food Chem. Toxicol., 28, 783-788, 1990.
13. US EPA, Guidelines for the Health Risk Assessment of Chemical Mixtures, US Environmental Protection Agency, Fed. Regist., 51(185), 34014-34025, 1986.
14. US EPA, Technical Support Document on Health Risk Assessment of Chemical Mixtures, EPA/600/8-90/064, Office of Health and Environmental Assessment, Environmental Assessment and Criteria Office, Cincinnati, Ohio, 1990.
15. Feron, V. J., Groten, J. P., Jonker, D., Cassee, F. R., and van Bladeren, P. J., Risk assessment of simple (defined) mixtures of chemicals, in Toxicology and Air Pollution: Risk Assessment, Burgat-Sacaze, V., Descotes, J., Gaussens, P., and Leslie, G. B., Eds. Faculté de Médicine et de Pharmacie, Université de Bourgogne, Dijon, 1995, 31-42.
16. Bliss, C. I., The toxicity of poisons applied jointly, Ann. Appl. Biol., 26, 585-615, 1939.
17. Mumtaz, M. M., DeRosa, C. T., and Durkin, P. R., Approaches and challenges in risk assessments of chemical mixtures, in Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 565-598.
18. Kodell, R. L. and Pound, J. G., Assessing the toxicity of mixtures of chemicals, in Statistical Methods in Toxicological Research, Krewski, D. and Franklin, C., Eds., Gordon and Breach Science Publ., New York, 1988.
19. Reif, A. E., Synergism in carcinogenesis, J. Nat. Cancer Inst., 73, 25-39, 1984.
20. Weber, L. J., Anderson, P., Muska, C., Yinger, E. K., and She-Hon, D., Concentration and response addition of mixtures of toxicants using lethality, growth and organ system studies. Presented at the ASA/EPA Conference on Joint Toxicity, Washington, DC, 1987.
21. Cassee, F. R., Arts, J. H. E., Groten, J. P., and Feron, V. J., Sensory irritation to mixtures of formaldehyde, acrolein, and acetaldehyde in rats, Arch. Toxicol., 70, 329-337, 1996.
22. Pöch, G., Dittrich, P., Reiffenstein, R. J., Lenk, W., and Schuster, A., Evaluation of experimental combined toxicity by use of dose frequency curves: comparison with theoretical additivity as well as independence, Can. J. Physiol. Pharmacol., 68, 1338-1345, 1990.
23. Loewe, S., and Muischnek, H., Über Kombinationswirkungen, Arch. Exp. Pathol. Pharmak., 114, 313-326, 1926.
24. Carter, W. H., Gennings, C., Staniswalis, J. G., Campbell, E. D., and White, K. L., A statistical approach to the construction and analysis of isobolograms, J. Am. Coll. Toxicol., 963-973, 1988.
25. Yang, R. S. H. and Rauckman, E. J., Toxicological studies of chemical mixtures of environmental concern at the National Toxicology Program: Health effects of groundwater contaminants, Toxicology, 7, 15-34, 1987.
26. Jonker, D., Jones, M. A., van Bladeren, P. J., Woutersen, R. A., Til, H. P., and Feron, V. J., Acute (24 h) toxicity of a combination of four nephrotoxicants in rats compared with the toxicity of the individual compounds, Food Chem. Toxicol., 31, 45-52, 1993.
27. Jonker, D., Woutersen, R. A., van Bladeren, P. J., Til, H. P., and Feron, V. J., Subacute (4-week) oral toxicity of a combination of four nephrotoxins in rats: comparison with the toxicity of the individual compounds, Food Chem. Toxicol., 31, 125-136, 1993.
28. Chaturvedi, A. K., Toxicological evaluation of mixtures of ten widely used pesticides, J. Appl. Toxicol., 13, 183-188, 1993.
29. Heindel, J. J., Chapin, R. E., Gulati, D. K., George, J. D., Price, C. J., Marr, M. C., Myers, C. B., Barnes, L. H., Fail, P.A., Grizzle, T. B., Schwetz, B. A., and Yang, R. S. H., Assessment of the reproductive and developmental toxicity of pesticide/fertilizer mixtures based on confirmed pesticide contamination in California and Iowa groundwater, Fund. Appl. Toxicol., 22, 605-621, 1994.
30. Ito, N., Hasegawa, K., Imaida, K., Kurat, Y., Hagiwara, A., and Shirai, T., Effect of ingestion of 20 pesticides in combination at acceptable daily intake levels on rat liver carcinogenesis, Food Chem. Toxicol., 33, 159-163, 1995.
31. Miners, J. O., Veronese, M. E. and Bricket, D. J., In vitro approaches for the prediction of human drug metabolism. Chap. 31. Annual Reports in Medical Chemistry, 29, 307-316, 1994.
32. Houston, J. B., Relevance of in vitro kinetic parameters to in vivo metabolism of xenobiotics, Toxic. In Vitro, 8, 507-512, 1994.
33. Houston, J. B., Relevance of in vitro drug metabolism data in predicting in vivo metabolic clearance, Biochem. Pharmacol., 47, 1469-1479, 1994.
34. Andersen, M. E., Clewell, III, H. J., and Frederick, C. G., Applying simulation modeling to problems in toxicology and risk assessment - a short perspective. Toxicol. Appl. Pharmacol., 133, 181-187, 1995.
35. Leung, W.-W and Paustenbach, D.J., Physiologically based pharmacokinetic and pharmacodynamic modeling in health risk assessment and characterization of hazardous substances, Toxicol. Lett., 79, 55-65, 1995.
36. Fiserova-Bergerova, V., Extrapolation of physiological parameters for physiologically based simulation models, Toxicol. Lett., 79, 77-86, 1995.
37. Yang, R. S. H., El-Masri, H.A., Thomas, R. S., Constan, A. A. and Tessari, J. D., The application of physiologically based pharmacokinetc/pharmacodynamic (PBPK/PD) modeling for exploring risk assessment approaches of chemical mixtures, Toxicol. Lett., 79, 193-200, 1995.
38. Andersen, M. E., Clewell, III, H. J., Gargas, M. L., Smith, F. A., and Reitz, R. H., Physiologically based pharmacokinetics and the risk assessment for methylene chloride, Toxicol. Appl. Pharmacol., 87, 185-205, 1987.
39. Ploemen, J. H .T. M., Wormhoudt, L. W., Haenen, G. R. M. M., Oudshoorn, M. J., Commandeur, J. N. M., Vermeulen, N. P. E., de Waziers, I., Beaune, P. H., Watabe, T., and van Bladeren P. J., The use of human in vitro metabolic parameters to explore the risk of hazardous compounds: the case of ethylene dibromide, Toxicol. Appl. Pharmacol., 193, 56-64, 1997.
40. Wolf, C. R., Metabolic factors in cancer susceptibility, Cancer Surv., 9, 437-473, 1990.
41. Hissink, A. M., Oudshoorn, M. J., Van Ommen, B., Haenen, G. R. M. M., and Van Bladeren, P. J., Differences in cytochrome P450-mediated biotransformation of 1,2-dichlorobenzene by rat and man: implications for human risk assessment, Chem. Res. Tox., 9(8), 1249-1256, 1996.
42. Gessner, P. K., A straightforward method for the study of drug interactions: an isobolographic analysis primer, J. Am. Col. Toxicol., 7, 987-1012, 1988.
43. Berenbaum, M. C., Criteria for analyzing interactions between biologically active agents, Adv. Cancer. Res., 35, 269-335, 1981.
44. Greco, W. R., Park, H. S., and Rustum, Y. M., Application of a new approach for the quantitation of drug synergism to the combination of cis-diamminedichloroplatinum and 1-β-arabinofuranosylcytosine, Cancer Res., 50, 5318-5327, 1990.
45. Greco, W. R., Bravo, G., and Parsons, J. C., The search for synergy: a critical review from a response surface perspective, Pharmacol. Rev., 47, 332-385, 1995.
46. Pöch, G. and Reiffenstein, R. J., Inappropriate and wrong conclusions derived from isobolograms, Arch. Complex Environ. Studies, 6, 33-36, 1994.
47. Loewe, S., The problem of synergism and antagonism of combined drugs, Arzneim. Forsch., 3, 285-290, 1953.
48. Smuziel, I. and Nias, A. H. W., Isobologram analysis of the combined effects of anti-tumor platinum complexes and ionizing radiation on mammalian cells, Br. J. Cancer, 42, 292-296, 1980.
49. Gennings, C., Dawson, K. S., Carter, W. H., and Myers, R. H., Interpreting plots of a multidimensional dose response surface in a parallel coordinate system, Biometrics, 46, 719-735, 1990.
50. Pöch, G., Evaluation of combined effects with respect to independent action, Arch. Compl. Environ. Studies, 3, 65-74, 1991.
51. Pöch, G., Combined Effects of Drugs and Toxic Agents: Modern Evaluation in Theory and Practice, Springer Verlag, New York, 1993.
52. Carter, W .H. and Gennings, C., Analysis of chemical combinations: relating isobolograms to response surfaces, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 643-664.
53. Plummer, J. L. and Short, T. G., Statistical modeling of the effects of drug combinations. J. Pharmacol. Methods, 23, 297-309, 1990.
54. Schoen, E. D., Statistical designs in combination toxicology: a matter of choice, Food Chem. Toxicol., 34, 1059-1065, 1996.
55. Box, G. E. P., Hunter, W. G., and Hunter, J. S., Statistics for Experimenters, John Wiley & Sons, New York, 1978, 653.
56. Svengaard, D. J. and Hertzberg, R. C., Statistical methods for toxicological evaluation, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994 599-642.
57. Nesnow, S., Mechanistic linkage between DNA adducts, mutations in oncogenes, and tumorgenesis of carcinogenic polycyclic aromatic hydrocarbons in strain A/J mice, in Chemical Mixtures and Quantitative Risk Assessment, Abstract of the Second Annual HERL Symposium, November 7 to 10, Raleigh, NC, 1994.
58. Narotsky, M. G., Weller, E. A., Chinchilli, V. M., and Kevlock, R. J., Nonadditive developmental toxicity of mixtures of trichloroethylene (di(2-ethyl-hexyl)phtalate, and heptachlor in a 5x5x5 design, Fund. Appl. Toxicol., 27, 203-216, 1995.
59. Eide, I. and Zahlsew, K., Inhalation experiments with mixtures of hydrocarbons. Experimental design, statistics and interpretation of kinetics and possible interactions. Arch. Toxicol., 70, 397-404, 1996.
60. Plackett, R. L. and Burman, J. P., The design of optimum multifactorial experiments, Biomatrika, 33, 305-339, 1946.
61. Groten, J. P., Sinkeldam, E. J., Muys, T., Luten, J. B., and van Bladeren, P. J., Interaction of dietary Ca, P, Mg, Mn, Cu, Fe, Zn, and Se with the accumulation and oral toxicity of cadmium in rats, Food Chem. Toxicol., 29, 249-258, 1991.
62. Eriksson, L., Jonsson, Hellberg, E. J., Lindgren, F., Skagerberg, B., Sjöström, M., Wold, S., and Berglind, R., A strategy for ranking environmentally occurring chemicals. III. Multivariate quantitative structure-activity relationships for halogenated aliphatics, Environ. Toxicol. Chem., 9, 1339-1351, 1991.
63. Groten, J. P., Schoen, E. D., van Bladeren, P. J., and Feron, V. J., Subacute toxicity of a combination of nine chemicals in rats: a two-level factorial design to predict interactive effects, Toxicologist, Abstract no. 1153, 1994.
64. Groten, J. P., Schoen, E. D., van Bladeren, P. J., Kuper, F. C. F., van Zorge, J. A., and Feron, V. J., Subacute toxicity of a combination of nine chemicals in rats: detecting interactive effects with a two-level factorial design, Fund. Appl. Toxicol., 36, 15-29, 1997.
65. Berenbaum, M. C., The expected effect of a combination of agents: the general solution, J. Theor. Biol., 114, 413-431, 1985.
66. Gennings, C., An efficient experimental design for detecting departure from additivity in mixtures of many chemicals, in Chemical Mixtures and Quantitative Risk Assessment, Abstract of the Second Annual HERI symposium, November 7 to 10, 1994, Raleigh, NC.
67. Portier, J. C. and Sherman, C. D., Potential effects of chemical mixtures on the carcinogenic process within the context of the mathematical model, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 665-686.
68. ILSI, Disinfection byproducts in drinking water: critical issues in health effects research, International Life Sciences Institute, Health and Environmental Sciences Institute, Washington, D.C., 1996, 168.
69. Fay, R. M. and Feron, V. J., Complex mixtures: hazard identification and risk assessment, Food Chem. Toxicol., 34, 1175-1176, 1996
70. Jonker, D., Woutersen, R. A., van Bladeren, P. J., Til, H. P., and Feron, V. J., 4-week oral toxicity study of a combination of eight chemicals in rats: comparison with the toxicity of the individual compounds, Food Chem. Toxicol., 28, 623-631, 1990.
71. Groten, J. P., Schoen, E. D., and Feron, V. J., Use of factorial designs in combination toxicity studies, Food Chem. Toxicol., 34, 1083-1089, 1996.
72. Cassee, F. R., Groten, J. P., and Feron, V. J., Changes in the nasal epithelium of rats exposed by inhalation to mixtures of formaldehyde, acetaldehyde and acrolein, Fund. Appl. Toxicol., 29, 208-218, 1996.
73. Cassee, F. R., Groten, J. P., and Feron, V. J., Combined exposure of rat upper respiratory tract epithelium to aldehydes, Hum. Exp. Toxicol., 13, 726, 1994.
74. 73a. Cassee, F. R., Stenhuis, W. H., Groten, J. P., and Feron, V. J., Toxicity of formaldehyde and acrolein mixtures: in vitro studies using nasal epethelial cells. Exp. Toxic. Pathol., 48, 481-483, 1996.
75. Jonker, D., Woutersen, R. A., and Feron, V. J., Toxicity of mixtures of nephrotoxicants with similar or dissimilar mode of action, Food Chem. Toxicol., 34, 1075-1082, 1996.
76. National Research Council, Selected Issues in Risk assessment. II. Mixtures (Drinking Water and Health). Vol. 9. Natl. Acad. Press, Washington, DC, 1989, 95-184.
77. Mumtaz, M. M. and Durkin, P. D., A weight of evidence approach for assessing interactions in chemical mixtures, Toxicol. Ind. Health, 8, 377-406, 1992.
78. Seed, J., Brown, R. P., Olin, S. S., and Foran, J. A., Chemical mixtures: current risk assessment methodologies and future directions, Reg. Toxicol. Pharmacol., 22, 76-94, 1995.
79. DeRosa, C. R., Johnson, B. L., Fay, M., Hansen, H., and Mumtaz, Public health implications of hazardous waste sites: findings, assessment and research, Food Chem. Toxicol., 34, 1131-1138, 1996.
80. McClellan, R. O., Foreword, in Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, xxi-xxiv.
81. Cassee, F. R. and V. J. Feron, Biochemical and histopathological changes in nasal epithelium of rats after 3-day intermittent exposure to formaldehyde and ozone alone or in combination, Toxicol. Lett., 72, 257-268, 1994.
82. Reuzel, P. G. J., Wilmer, J. W. G. M., Woutersen, R. A., Zwart, A., Rombout, P. J. A., and Feron, V. J., Interactive effects of ozone and formaldehyde on the nasal respiratory lining epithelium in rats, J. Toxicol. Environm. Health, 29, 279-292, 1990.
83. Simmons, J. E., Nephrotoxicity resulting from multiple chemical exposures and chemical interactions, in Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 335-360.
84. Mautz, W. J., Kleinman, M. T., Phalen, R. F., and Crocker, T. T., Effects of exercise exposure on toxic interactions between inhaled oxidant and aldehyde air pollutants, J. Toxicol. Environm. Health, 25, 165-177, 1988.
85. Mumtaz, M. M., DeRosa, C. R., Groten, J. P., Feron, V. J., Hansen, H., and Durkin, P. R., Estimation of toxicity of chemical mixtures through modeling of chemical interactions. Environ. Health. Perspect., in press.