Toxicological Evaluation and Risk Assessment of Chemical Mixtures

References

• Krishnan, K. and Brodeur, J., Toxicologi- cal consequences of combined exposure to en- vironmental pollutants, Arch. Complex Envi- ron. Studies, 3, 1–104, 1991.
   Google Scholar
• Yang, R. S. H., Introduction to the toxicol- ogy of chemical mixtures, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Aca- demic Press, San Diego, 1994, 1–10.
   Google Scholar
• Calabrese, E. J., Multiple Chemical Interac- tions, Lewis Publishers, Chelsea, 1991, 704.
   Google Scholar
• Mumtaz, M. M., Sipes, I. G., Clewell, H. J., and Yang, R. S. H., Risk assessment of chem- ical mixtures: biologic and toxicologic issues, Fund. Appl. Toxicol., 21, 258–269, 1993.
   PubMedGoogle Scholar
• Feron, V. J., Jonker, D., van den Berg, M., Bogaards, J. J. P., Groten, J. P., and van Bladeren, P. J., Some principles of combina- tion toxicology applied to defined mixtures of (chlorinated organic) chemicals, in: Proceed- ings of the Conference on Chlorinated Organ- ic Chemicals: Their Effect on Human Health and the Environment, The Toxicology Forum, Berlin, 1994, 390–421.
   Google Scholar
• Feron, V. J., Groten, J. P., Jonker, D., Cassee, F. R., and van Bladeren, P. J., Toxi- cology of chemical mixtures: challenges for today and the future, Toxicology, 105, 415– 427, 1995.
   PubMed Web of Science ®Google Scholar
• Feron, V. J., Woutersen, R. A., Arts, J. H. E., Cassee, F. R., de Vrijer, Fl., and van Bladeren, P. J., Safety evaluation of the mix- ture of chemicals at a specific workplace: theo- retical considerations and a suggested two- step procedure, Toxicol. Lett., 76, 47–55, 1995.
   PubMed Web of Science ®Google Scholar
• Feron, V. J. and Bolt, H. M., Combination toxicology, Food Chem. Toxicol., 34, 1025– 1185, 1996.
   Web of Science ®Google Scholar
• Yang, R. S. H., Toxicology of Chemical Mix- tures, Academic Press, San Diego, 1994, 720.
   Google Scholar
• Steel, G. G. and Peckham, M. J., Exploit- able mechanisms in combined radiotherapy- chemotherapy: the concept of additivity, Int. J. Radiation Oncol. Biol. Phys., 5, 85–91, 1979.
   PubMed Web of Science ®Google Scholar
• Henschler, D., Bolt, H. M., Jonker, D., Pieters, M. N., and Groten, J. P., Experi- mental designs and risk assessment in combi- nation toxicology: panel discussion, Food Chem. Toxicol., 34, 1183–1185, 1996.
   PubMed Web of Science ®Google Scholar
• Feron, V. J., van Bladeren, P. J., and Hermus, R. J. J., A view point on the extrap- olation of toxicological data from animals to man, Food Chem. Toxicol., 28, 783–788, 1990.
   PubMed Web of Science ®Google Scholar
• US EPA, Guidelines for the Health Risk As- sessment of Chemical Mixtures, US Environ- mental Protection Agency, Fed. Regist., 51(185),34014–34025, 1986.
   Google Scholar
• US EPA, Technical Support Document on Health Risk Assessment of Chemical Mix- tures, EPA/600/8-90/064, Office of Health and Environmental Assessment, Environmen- tal Assessment and Criteria Office, Cincin- nati, Ohio, 1990.
   Google Scholar
• Feron, V. J., Groten, J. P., Jonker, D., Cassee, F. R., and van Bladeren, P. J., Risk assessment of simple (defined) mixtures of chem- icals, 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.
   Google Scholar
• Bliss, C. I., The toxicity of poisons applied jointly, Ann. Appl. Biol., 26, 585–615, 1939.
   Google Scholar
• Mumtaz, M. M., DeRosa, C. T., and Durkin, P. R., Approaches and challenges in risk as- sessments of chemical mixtures, in Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 565–598.
   Google Scholar
• Kodell, R. L. and Pound, J. G., Assessing the toxicity of mixtures of chemicals, in Sta- tistical Methods in Toxicological Research, Krewski, D. and Franklin, C., Eds., Gordon and Breach Science Publ., New York, 1988.
   Google Scholar
• Reif, A. E., Synergism in carcinogenesis, J. Nat. Cancer Inst., 73, 25–39, 1984.
   PubMedGoogle Scholar
• Weber, L. J., Anderson, P., Muska, C., Yinger, E. K., and She-Hon, D., Concentra- tion and response addition of mixtures of toxi- cants using lethality, growth and organ system studies. Presented at the ASA/EPA Confer- ence on Joint Toxicity, Washington, DC, 1987.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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 theoreti- cal additivity as well as independence, Can. J. Physiol. Pharmacol., 68, 1338–1345, 1990.
   PubMed Web of Science ®Google Scholar
• Loewe, S., and Muischnek, H., Über Kombinationswirkungen, Arch. Exp. Pathol. Pharmak., 114, 313–326, 1926.
   Google Scholar
• Carter, W. H., Gennings, C., Staniswalis, J. G., Campbell, E. D., and White, K. L., A statistical approach to the construction and anal- ysis of isobolograms, J. Am. Coll. Toxicol., 963– 973, 1988.
   Google Scholar
• Yang, R. S. H. and Rauckman, E. J., Toxi- cological studies of chemical mixtures of environmental concern at the National Toxi- cology Program: Health effects of groundwa- ter contaminants, Toxicology, 7, 15–34, 1987.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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 toxic- ity of the individual compounds, Food Chem. Toxicol., 31, 125–136, 1993.
   PubMed Web of Science ®Google Scholar
• Chaturvedi, A. K., Toxicological evaluation of mixtures of ten widely used pesticides, J. Appl. Toxicol., 13, 183–188, 1993.
   PubMed Web of Science ®Google Scholar
• 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., Assess- ment of the reproductive and developmental toxicity of pesticide/fertilizer mixtures based on confirmed pesticide contamination in Cali- fornia and Iowa groundwater, Fund. Appl. Toxi- col., 22, 605–621, 1994.
   PubMedGoogle Scholar
• Ito, N., Hasegawa, K., Imaida, K., Kurat, Y., Hagiwara, A., and Shirai, T., Effect of inges- tion of 20 pesticides in combination at accept- able daily intake levels on rat liver carcinogen- esis, Food Chem. Toxicol., 33, 159–163, 1995.
   PubMed Web of Science ®Google Scholar
• 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.
   Web of Science ®Google Scholar
• Houston, J. B., Relevance of in vitro kinetic parameters to in vivo metabolism of xenobi- otics, Toxic. In Vitro, 8, 507–512, 1994.
   PubMed Web of Science ®Google Scholar
• Houston, J. B., Relevance of in vitro drug metabolism data in predicting in vivo meta- bolic clearance, Biochem. Pharmacol., 47, 1469–1479, 1994.
   PubMed Web of Science ®Google Scholar
• Andersen, M. E., Clewell, III, H. J., and Frederick, C. G., Applying simulation mod- eling to problems in toxicology and risk assess- ment—a short perspective. Toxicol. Appl. Phar- macol., 133, 181–187, 1995.
   PubMed Web of Science ®Google Scholar
• Leung, W.-W and Paustenbach, D. J., Physi- ologically based pharmacokinetic and pharma- codynamic modeling in health risk assessment and characterization of hazardous substances, Toxicol. Lett., 79, 55–65, 1995.
   PubMed Web of Science ®Google Scholar
• Fiserova-Bergerova, V., Extrapolation of phys- iological parameters for physiologically based simulation models, Toxicol. Lett., 79, 77–86, 1995.
   PubMed Web of Science ®Google Scholar
• Yang, R. S. H., El-Masri, H.A., Thomas, R. S., Constan, A. A. and Tessari, J. D., The application of physiologically based phar- macokinetc/pharmacodynamic (PBPK/PD) modeling for exploring risk assessment ap- proaches of chemical mixtures, Toxicol. Lett., 79, 193–200, 1995.
   PubMed Web of Science ®Google Scholar
• Andersen, M. E., Clewell, III, H. J., Gargas, M. L., Smith, F. A., and Reitz, R. H., Physi- ologically based pharmacokinetics and the risk assessment for methylene chloride, Toxicol. Appl. Pharmacol., 87, 185–205, 1987.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• Wolf, C. R., Metabolic factors in cancer sus- ceptibility, Cancer Surv., 9, 437–473, 1990.
   PubMedGoogle Scholar
• 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-dichlo- robenzene by rat and man: implications for hu- man risk assessment, Chem. Res. Tox., 9(8),1249–1256, 1996.
   Google Scholar
• Gessner, P. K., A straightforward method for the study of drug interactions: an isobolographic analysis primer, J. Am. Col. Toxicol., 7, 987– 1012, 1988.
   Google Scholar
• Berenbaum, M. C., Criteria for analyzing in- teractions between biologically active agents, Adv. Cancer. Res., 35, 269–335, 1981.
   PubMed Web of Science ®Google Scholar
• Greco, W. R., Park, H. S., and Rustum, Y. M., Application of a new approach for the quantitation of drug synergism to the combina- tion of cis-diamminedichloroplatinum and 1- β-arabinofuranosylcytosine, Cancer Res., 50, 5318–5327, 1990.
   PubMed Web of Science ®Google Scholar
• Greco, W. R., Bravo, G., and Parsons, J. C., The search for synergy: a critical review from a response surface perspective, Pharma- col. Rev., 47, 332–385, 1995.
   Web of Science ®Google Scholar
• Pöch, G. and Reiffenstein, R. J., Inappropri- ate and wrong conclusions derived from isobo- lograms, Arch. Complex Environ. Studies, 6, 33–36, 1994.
   Google Scholar
• Loewe, S., The problem of synergism and antag- onism of combined drugs, Arzneim. Forsch., 3, 285–290, 1953.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Pöch, G., Evaluation of combined effects with respect to independent action, Arch. Compl. Environ. Studies, 3, 65–74, 1991.
   Google Scholar
• Pöch, G., Combined Effects of Drugs and Tox- ic Agents: Modern Evaluation in Theory and Practice, Springer Verlag, New York, 1993.
   Google Scholar
• Carter, W .H. and Gennings, C., Analysis of chemical combinations: relating isobolograms to response surfaces, in: Toxicology of Chemi- cal Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 643–664.
   Google Scholar
• Plummer, J. L. and Short, T. G., Statistical modeling of the effects of drug combinations. Pharmacol. Methods, 23, 297–309, 1990.
   PubMedGoogle Scholar
• Schoen, E. D., Statistical designs in combina- tion toxicology: a matter of choice, Food Chem. Toxicol., 34, 1059–1065, 1996.
   PubMed Web of Science ®Google Scholar
• Box, G. E. P., Hunter, W. G., and Hunter, S., Statistics for Experimenters, John Wiley & Sons, New York, 1978, 653.
   Google Scholar
• Svengaard, D. J. and Hertzberg, R. C., Sta- tistical methods for toxicological evaluation, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994 599–642.
   Google Scholar
• Nesnow, S., Mechanistic linkage between DNA adducts, mutations in oncogenes, and tumorgen- esis of carcinogenic polycyclic aromatic hydrocar- bons in strain A/J mice, in Chemical Mixtures and Quantitative Risk Assessment, Abstract of the Second Annual HERL Symposium, No- vember 7 to 10, Raleigh, NC, 1994.
   Google Scholar
• Narotsky, M. G., Weller, E. A., Chinchilli, V. M., and Kevlock, R. J., Nonadditive de- velopmental toxicity of mixtures of trichloro- ethylene (di(2-ethyl-hexyl)phtalate, and hep- tachlor in a 5x5x5 design, Fund. Appl. Tox- icol., 27, 203–216, 1995.
   PubMedGoogle Scholar
• Eide, I. and Zahlsew, K., Inhalation experi- ments with mixtures of hydrocarbons. Ex- perimental design, statistics and interpreta- tion of kinetics and possible interactions. Arch. Toxicol., 70, 397–404, 1996.
   Google Scholar
• Plackett, R. L. and Burman, J. P., The de- sign of optimum multifactorial experiments, Biomatrika, 33, 305–339, 1946.
   Web of Science ®Google Scholar
• Groten, J. P., Sinkeldam, E. J., Muys, T., Luten, J. B., and van Bladeren, P. J., Inter- action 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.
   PubMed Web of Science ®Google Scholar
• 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, Envi- ron. Toxicol. Chem., 9, 1339–1351, 1991.
   Web of Science ®Google Scholar
• 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 ef- fects, Toxicologist, Abstract no. 1153, 1994.
   Google Scholar
• 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 combina- tion of nine chemicals in rats: detecting inter- active effects with a two-level factorial design, Fund. Appl. Toxicol., 36, 15–29, 1997.
   PubMedGoogle Scholar
• Berenbaum, M. C., The expected effect of a combination of agents: the general solution, J. Theor. Biol., 114, 413–431, 1985.
   PubMed Web of Science ®Google Scholar
• Gennings, C., An efficient experimental de- sign for detecting departure from additivity in mixtures of many chemicals, in Chemical Mix- tures and Quantitative Risk Assessment, Ab- stract of the Second Annual HERl sympo- sium, November 7 to 10, 1994, Raleigh, NC.
   Google Scholar
• Portier, J. C. and Sherman, C. D., Potential effects of chemical mixtures on the carcino- genic process within the context of the mathe- matical model, in: Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 665–686.
   Google Scholar
• ILSI, Disinfection byproducts in drinking water: critical issues in health effects research, International Life Sciences Institute, Health and Environmental Sciences Institute, Wash- ington, D.C., 1996, 168.
   Google Scholar
• Fay, R. M. and Feron, V. J., Complex mix- tures: hazard identification and risk assess- ment, Food Chem. Toxicol., 34, 1175–1176, 1996
   PubMed Web of Science ®Google Scholar
• 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 toxic- ity of the individual compounds, Food Chem. Toxicol., 28, 623–631, 1990.
   PubMed Web of Science ®Google Scholar
• Groten, J. P., Schoen, E. D., and Feron, V. J., Use of factorial designs in combination tox- icity studies, Food Chem. Toxicol., 34, 1083– 1089, 1996.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• Cassee, F. R., Groten, J. P., and Feron, V. J., Combined exposure of rat upper respiratory tract epithelium to aldehydes, Hum. Exp. Tox- icol., 13, 726, 1994.
   Google Scholar
• 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.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• National Research Council, Selected Issues in Risk assessment. II. Mixtures (Drinking Water and Health). Vol. 9. Natl. Acad. Press, Washington, DC, 1989, 95–184.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• DeRosa, C. R., Johnson, B. L., Fay, M., Hansen, H., and Mumtaz, Public health im- plications of hazardous waste sites: findings, assessment and research, Food Chem. Toxicol., 34, 1131–1138, 1996.
   PubMed Web of Science ®Google Scholar
• McClellan, R. O., Foreword, in Toxicology of Chemical Mixtures, Yang, R. S. H., Ed., Aca- demic Press, San Diego, 1994, xxi–xxiv.
   Google Scholar
• Cassee, F. R. and V. J. Feron, Biochemical and histopathological changes in nasal epithe- lium of rats after 3-day intermittent exposure to formaldehyde and ozone alone or in combi- nation, Toxicol. Lett., 72, 257–268, 1994.
   PubMed Web of Science ®Google Scholar
• 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. Envi- ronm. Health, 29, 279–292, 1990.
   PubMed Web of Science ®Google Scholar
• Simmons, J. E., Nephrotoxicity resulting from multiple chemical exposures and chemical in- teractions, in Toxicology of Chemical Mix- tures, Yang, R. S. H., Ed., Academic Press, San Diego, 1994, 335–360.
   Google Scholar
• Mautz, W. J., Kleinman, M. T., Phalen, R. F., and Crocker, T. T., Effects of exercise expo- sure on toxic interactions between inhaled ox- idant and aldehyde air pollutants, J. Toxicol. Environm. Health, 25, 165–177, 1988.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar