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Review Article

Retrospective evaluation of the impact of functional immunotoxicity testing on pesticide hazard identification and risk assessment

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Pages 407-419 | Received 01 Aug 2013, Accepted 08 Jan 2014, Published online: 07 Mar 2014

References

  • Basketter DA, Clewell H, Kimber I, Rossi A, Blaauboer B, Burrier R, et al. (2012). t(4) Report. A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing. ALTEX, 29, 5–15.
  • Boverhof DR, Ladics G, Luebke B, Botham J, Corsini E, Evans E, Germolec D, Holsapple M, Loveless SE, Lu H, Van Der Laan JW, White KL Jr, Yang Y. (2014). Approaches and considerations for the assessment of immunotoxicity for environmental chemicals: a workshop summary. Regul Toxicol Pharmacol, 68, 96–107.
  • Cooper RL, Lamb JC, Barlow SM, Bentley K, Brady AM, Doerrer NG, et al. (2006). A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol, 36, 69–98.
  • Creton S, Dewhurst IC, Earl LK, Gehen SC, Guest RL, Hotchkiss JA, et al. (2010). Acute toxicity testing of chemicals-opportunities to avoid redundant testing and use alternative approaches. Crit Rev Toxicol, 40, 50–83.
  • Dellarco V, Henry T, Sayre P, Seed J, Bradbury S. (2010a). Meeting the common needs of a more effective and efficient testing and assessment paradigm for chemical risk management. J Toxicol Environ Health B Crit Rev, 13, 347–60.
  • Dellarco VL, Rowland J, May B. (2010b). A retrospective analysis of toxicity studies in dogs and impact on the chronic reference dose for conventional pesticide chemicals. Crit Rev Toxicol, 40, 16–23.
  • Doe JE, Boobis AR, Blacker A, Dellarco V, Doerrer NG, Franklin C, et al. (2006). A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. Crit Rev Toxicol, 36, 37–68.
  • EPA. (2007). Environmental Protection Agency, 40 CFR Parts 9 and 158. Pesticides; Data Requirements for Conventional Chemicals. Federal Register, Vol. 72, No 207/Friday, October 26, 1007.
  • Harleman JH. (2000). Approaches to the identification and recording of findings in the lymphoreticular organs indicative for immunotoxicity in regulatory type toxicity studies. Toxicology, 142, 213–9.
  • ICH. (2005). ICH Harmonised Tripartite Guideline S8: Immunotoxicity Studies for Human Pharmaceuticals. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S8/Step4/S8_Guideline.pdf
  • ICIS. (1998). Report of validation study of assessment of direct immunotoxicity in the rat. The ICICIS Group Investigators. International Collaborative Immunotoxicity Study. Toxicology, 125, 183–201.
  • Jerne NK, Nordin AA. (1963). Plaque formation in agar by single antibody-producing cells. Science, 140, 405.
  • Kobel W, Fegert I, Billington R, Lewis R, Bentley K, Bomann W, et al. (2010). A 1-year toxicity study in dogs is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides. Crit Rev Toxicol, 40, 1–15.
  • Krewski D, Acosta D, Andersen M, Anderson H, Bailar JC, Boekelheide K, et al. (2010). Toxicity testing in the 21st century: a vision and a strategy. J Toxicol Environ Health B Crit Rev, 13, 51–138.
  • Kuper CF, Harleman JH, Richter-Reichelm HB, Vos JG. (2000). Histopathologic approaches to detect changes indicative of immunotoxicity. Toxicol Pathol, 28, 454–66.
  • Ladics GS. (2007). Use of SRBC antibody responses for immunotoxicity testing. Methods, 41, 9–19.
  • Luster MI, Munson AE, Thomas PT, Holsapple MP, Fenters JD, White KL, Jr., et al. (1988). Development of a testing battery to assess chemical-induced immunotoxicity: National Toxicology Program's guidelines for immunotoxicity evaluation in mice. Fundam Appl Toxicol, 10, 2–19.
  • Luster MI, Portier C, Pait DG, White KL, Gennings C, Munson AE, Rosenthal GJ. (1992). Risk assessment in immunotoxicology. 1. sensitivity and predictability of immune tests. Fundam Appl Toxicol, 18, 200–210.
  • NAS. (2007). National Academy of Sciences. Toxicity Testing in the Twenty-first Century: A Vision and a Strategy. National Academy Press, Washington, DC.
  • Pauels HG, Taylor J. (2010). Immunotoxicity testing: ICH guideline S8 and related aspects. Pharmaceutical Sciences Encyclopedia. In: Gad SC., Ed. New York: Wiley. pp. 1–40.
  • Plunkett LM, Kaplan AM, Becker RA. (2010). An enhanced tiered toxicity testing framework with triggers for assessing hazards and risks of commodity chemicals. Regul Toxicol Pharmacol, 58, 382–94.
  • Pruett SB, Ensley DK, Crittenden PL. (1993). The role of chemical-induced stress responses in immunosuppression - a review of quantitative associations and cause-effect relationships between chemical-induced stress responses and immunosuppression. J Toxicol Environ Health, 39, 163–192.
  • Putman E, Van Der Laan JW, Van Loveren H. (2003). Assessing immunotoxicity: guidelines. Fundam Clin Pharmacol, 17, 615–626.
  • SANCO. (2010). European Commission. Annex to SANCO 11802/2010/rev.7; Part B 02.02.
  • Schulte A, Althoff J, Ewe S, Richter-Reichhelm HB. (2002). Two immunotoxicity ring studies according to OECD TG 407-comparison of data on cyclosporin A and hexachlorobenzene. Regul Toxicol Pharmacol, 36, 12–21.
  • Temple L, Kawabata TT, Munson AE, White KL Jr. (1993). Comparison of ELISA and plaque-forming cell assays for measuring the humoral immune response to SRBC in rats and mice treated with benzo[a]pyrene or cyclophosphamide. Fundam Appl Toxicol, 21, 412–9.
  • USEPA. (2002). A Review of the Reference Dose and Reference Concentration Process: Final Report. Available at: http://www.epa.gov/raf/publications/pdfs/rfd-final.pdf
  • USEPA. (2005a). A Comparison of the Results of Studies on Pesticides from 12- or 24-Month Dog Studies with Dog Studies of Shorter Duration. In: Health Effects Division, U. E. P. A., Office of Pesticide Programs Ed. Available at: http://www.epa.gov/oscpmont/sap/meetings/2005/may2/dogstudymay05.pdf
  • USEPA. (2005b). FIFRA Scientific Advisory Panel (SAP) Meeting Minutes, May 5–6, 2005, A Set of Scientific Issues Being Considered by the Environmental Protection Agency Regarding: A Comparison of the Results of Studies on Pesticides from 1- or 2-Year Dog Studies of Shorter Duration. Available at: http://www.epa.gov/scipoly/sap/meetings/2005/050505_mtg.htm
  • USEPA. (2007). Environmental Protection Agency, 40 CFR Parts 9 and 158. Pesticides; Data Requirements for Conventional Chemicals. Federal Register, Vol. 72, No 207/Friday, October 26 , 1007.
  • USEPA. (2009). Immunotoxicity Test Guideline: Response to CropLife America’s Comments. Health Effects Division. Office of Pesticide Programs. US Environmental Protection Agency. Memorandum dated June 16, 2009.
  • USEPA (2013). A Retrospective Analysis of the Immunotoxicity Study (OCSPPTest Guideline No. 870.7800). Health Effects Division, Officeof Pesticide Programs. US Environmental Protection Agency. Memorandum dated February 2013.
  • Weaver JL, Tsutsui N, Hisada S, Vidal JM, Spanhaak S, Sawada J, et al. (2005). Development of the ICH guidelines for immunotoxicology evaluation of pharmaceuticals using a survey of industry practices. J Immunotoxicol, 2, 171–80.

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