Scientific Opinion on the identification of pesticides to be included in cumulative assessment groups on the basis of their toxicological profile

EFSA Journal

Volumn 11, Issue 7, 2013, Pages

[No Author Info available]

Author keywords

cumulative assessment grouping; Cumulative risk assessment; methodology; nervous system; thyroid; toxicological profile

Indexed keywords

EID: 85003798485     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2013.3293     Document Type: Article

References (77)

1. ATSDR (Agency for Toxic Substances and Disease Registry), 2003. Toxicological profile for pyrethrins and pyrethroids. U.S. Department of Health and Human Services, Public Health Service, 328 pp.
2. Banerjee BD, Seth V, Bhattacharya A, Pasha ST and Chakraborty AK, 1999. Biochemical effects of some pesticides on lipid peroxidation and free-radical scavengers. Toxicology Letters, 107, 33–47.
3. BfR (Bundesinstitut für Risikobewertung), 2006. Pesticide exposure and Parkinson's disease: the BfR believes there is an association but no causal relationship. BfR Opinion No. 033/2006, 27 June 2006.
4. Bliss CI, 1939. The toxicity of poisons applied jointly. Annals of Applied Biology, 26, 585–615.
5. Boobis AR, Ossendorp BC, Banasiak U, Hamey PY, Sebestyen I and Moretto A, 2008. Cumulative risk assessment of pesticide residues in food. Toxicology Letters, 180, 137–150.
6. Botts S, Jokinen MP, Isaacs KR, Meuten DJ and Tanaka N, 1991. Proliferative lesions of the thyroid and parathyroid glands. In: Guides for Toxicologic Pathology. STP/ARP/AFIP, Washington, DC.
7. ANSES/ICPS/RIVM (Agency for Food, Environmental and Occupational Health and Safety/International Centre for Pesticides and Health Risk Prevention/National Institute for Public Health and the Environment), 2013. Toxicological data analysis to support grouping of pesticide active substances for cumulative risk assessment of effects on liver, on the nervous system and on reproduction and development, 88 pp.
8. COT (Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment), 2002. Risk assessment of mixtures of pesticides and similar substances. Her Majesty's Stationary Office, London, United Kingdom, 298 pp.
9. Crofton KM, Craft ES, Hedge JM, Gennings C, Simmons JE, Carchman RA, Carter WH Jr, DeVito MJ, 2005. Thyroid-hormone-disrupting chemicals: evidence for dose-dependent additivity or synergism. Environmental Health Perspectives, 113, 1549–1554.
10. Dellarco VL, McGregor D, Berry Sir C, Cohen SM and Boobis AR, 2006. Thiazopyr and Thyroid Disruption: Case study within the context of the 2006 IPCS human relevance framework for analysis of a cancer mode of action. Critical Reviews in Toxicology, 36, 793–801.
11. DTU (Danish Technical University), 2012. Identification of Cumulative Assessment Groups of pesticides. External scientific report submitted to EFSA, 303 pp.
12. EFSA (European Food Safety Authority), 2008. Opinion of the Scientific Panel on Plant Protection products and their Residues to evaluate the suitability of existing methodologies and, if appropriate, the identification of new approaches to assess cumulative and synergistic risks from pesticides to human health with a view to set MRLs for those pesticides in the frame of Regulation (EC) 396/2005. The EFSA Journal 2008, 704, 1–84.
13. EFSA (European Food Safety Authority), 2009. Opinion on Risk Assessment for a selected group of pesticides from the triazole group to test possible methodologies to assess cumulative effects from exposure through food from these pesticides on human health. The EFSA Journal 2009, 7, 1167.
14. EFSA (European Food Safety Authority), 2012a. Scientific Committee. Guidance on selected default values to be used by the EFSA ScientificCommittee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal 2012;10(3):2579. [32 pp.]doi:10.2903/j.efsa.2012.2579.
15. EFSA (European Food Safety Autority), 2012b. Guidance on the Use of Probabilistic Methodology for Modelling Dietary Exposure to Pesticide Residues, EFSA Journal 2012 10,2839.
16. Flippin JL, Hedge JM, DeVito MJ, LeBlanc GA and Crofton KM, 2009. Predictive modeling of a mixture of thyroid hormone disrupting chemicals that affect production and clearance of thyroxine. International Journal of Toxicology, 28, 368–381.
17. Frith CH, Botts S, Jokinen MP, Eighmy JJ, Hailey JR, Morgan SJ and Chandra M, 2000. Nonproliferative lesions of the endocrine system in rats. In: Guides for Toxicological Pathology. STP/ARP/AFIP, Washington, DC.
18. Gilbert ME, Rovet J, Chen Z and Koibuchi N, 2012. Developmental thyroid hromone disruption: Prevalence, environmental contaminants and neurodevelopmental consequences. Neurotoxicology, 33, 842–852.
19. Gray DL, Warshawsky D, Xue W, Nines R, Wang Y, Yao R and Stoner GD, 2001. The effects of a binary mixture of benzo(a)pyrene and 7H-dibenzo(c,g)carbazole on lung tumors and K-ras oncogene mutations in strain A/J mice. Experimental Lung Research, 27(3), 245–253.
20. Haddow JE, Palomaki GE, Allan WC, Williams JR, Mitchell ML, Hermos RJ, Faix JD and Klein RZ. 1999. Maternal thyroid deficiency during pregnancy and subsequent neuropsycholocial development of the child. The New England Journal of Medicine 341, 549–555.
21. Hayden KM, Norton MC, Darcey D, Ostbye T, Zandi PP, Breitner JC and Welsh-Bohmer KA, 2010; Cache County Study Investigators. Occupational exposure to pesticides increases the risk of incident AD: the Cache County study. Neurology, 74, 1524–1530.
22. Hass U, Boberg J, Christiansen S, Jacobsen OR, Vinggard AM, Taxvig C, Poulsen ME, Herrmann SS, Jensen BH, Petersen A, Clemmensen LH and Axelstad M, 2012. Adverse effects on sexual development in rat offspring after low dose exposure to a mixture of endocrine disrupting pesticides. Reproductive Toxicology, 34(2), 261–274.
23. Hotchkiss AK, Parks-Saldutti LG, Ostby JS, Lambright C, Furr J, Vandenbergh JG and Gray LE, 2004. A mixture of the “antiandrogens” linuron and butyl benzyl phthalate alters sexual differentiation of the male rat in a cumulative fashion. Biology of Reproduction, 71(6):1852–1861.
24. IPCS (International Programme of Chemical Safety), 2009. Assessment of Combined Exposures to Multiple Chemicals: Report of a WHO/IPCS International Workshop on Aggregate/Cumulative Risk Assessment, WHO, Geneva, 75 pp.
25. IPCS (International Programme on Chemical Safety), 2001. Environmental Health Criteria 223. Neurotoxicity risk assessment for human health: principles and approaches. World Health Organization (WHO), Geneva, 223 pp.
26. Jacobsen PR, Axelstad M, Boberg J, Isling LK, Christiansen S, Mandrup KR, Berthelsen LO, Vinggaard AM and Hass H, 2012. Persistent developmental toxicity in rat offspring after low dose exposure to a mixture of endocrine disrupting pesticides. Reproductive Toxicology, 34(2), 237–250.
27. JMPR (Joint FAO/WHO Meetings of Experts on Pesticide Residues), 1998. Report of a consultation on interpretation of inhibition of acetylcholinesterase activity. Geneva 8–9 January 1998.
28. JMPR (Joint FAO/WHO Meetings on Pesticide Residues), 2005. Pesticide Residues in Food – 2005: joint FAO/WHO Meeting on Pesticide Residues JMPR toxicological evaluations 2005 (draft). Evaluations 2005 Part II – Toxicological.
29. JMPR (Joint FAO/WHO Meetings on Pesticide Residues), 2006. Pesticide Residues in Food – 2006: joint FAO/WHO Meeting on Pesticide Residues in food and the Environment and the WHO Core Assessment Group on Pesticide Residues.
30. Kamel F, Umbach DM, Bedlack RS, Richards M, Watson M, Alavanja MC, Blair A, Hoppin JA, Schmidt S and Sandler DP, 2012. Pesticide exposure and amyotrophic lateral sclerosis. Neurotoxicology, 33, 457–462.
31. Kenborg L, Lassen CF, Lander F and Olsen JH, 2012. Parkinson's disease among gardeners exposed to pesticides-a Danish cohort study. Scandinavian Journal of Work, Environment and Health, 38, 65–69.
32. Kitchen DN, Todd GC, Meyers DB and Paget C, 1979. Rat lymphocytic thyroiditis associated with ingestion of an immunosuppressive compound. Veterinary Pathology, 16, 722–729.
33. Kortenkamp A, 2007. Ten years of mixing cocktails: a review of combination effects of endocrinedisrupting chemicals. Environmental Health Perspectives, 115, 98–105.
34. Kortenkamp A, Backhaus T and Faust M, 2009. State of the Art Report on Mixture Toxicity, 31 pp. ULSOP - The School of Pharmacy of University of London.
35. Kortenkamp A, Evans R, Faust M, Kalberlah F, Scholze M and Schuhmacher-Wolz U, 2012. Investigation of the state of the science on combined actions of chemicals in food through dissimilar modes of action and proposal for science-based approach for performing related cumulative risk assessment. Supporting Publications 2012:EN-232. [233 pp.].
36. Knudsen LB, Madsen LW, Andersen S, Almholt K, de Boer AS, Drucker DJ, Gotfredsen C, Egerod FL, Hegelund AC, Jacobsen H, Jacobsen SD, Moses AC, Mølck AM, Nielsen HS, Nowak J, Solberg H, Thi TD, Zdravkovic M and Moerch U, 2010. Glucagon-like Peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology, 151, 1473–1486.
37. Kooistra L, Crawford S, van Baar Al, Brouwers EP and Pop VJ, 2006. Neonatal effects of maternal hypothyroidism during early pregnancy. Pediatrics, 117, 161–167.
38. Lewis RW, Billington R, Debryune E, Gamer A, Lang B, Carpaninin F, 2001. Recognition of adverse and nonadverse effects in toxicity studies. Toxicologic Pathology, 30, 66–74.
39. Loewe S and Muischneck H, 1926. Effect of combinations: mathematical basis of problem. Naunyn-Schmiedebergs Archiv für experimentelle Pathologie und Pharmakologie, 114, 313–326.
40. London L, Beseler C, Bouchard MF, Bellinger DC, Colosio C, Grandjean P, Harari R, Kootbodien T, Kromhout H, Little F, Meijster T, Moretto A, Rohlman DS and Stallones L, 2012. Neurobehavioral and neurodevelopmental effects of pesticide exposures. Neurotoxicology, 33, 887–896.
41. Lotti M, 1991. The pathogenesis of organophosphate polyneuropathy. Critical Reviews in Toxicology, 21, 465–487.
42. Luttik R and van Raaij MTM, 2001. Factsheets for the (eco)toxicological risk assessment strategy of the National Institute of Public Health and the Environment (RIVM). RIVM, Report 601516 007.
43. Malek AM, Barchowsky A, Bowser R, Youk A and Talbott EO, 2012. Pesticide exposure as a risk factor for amyotrophic lateral sclerosis: a meta-analysis of epidemiological studies: pesticide exposure as a risk factor for ALS. Environmental Research, 117, 112–119.
44. Meek ME, Boobis AR, Crofton KM, Heinemeyer G, Raa'J MV and Vickers C, 2011. Risk assessment of combined exposure to multiple chemicals: a WHO/IPCS framework. Regulatory Toxicology and Pharmacology S1–S14.
45. Mileson BE, Chambers JE, Chen WL, Dettbarn W, Ehrich M, Eldefrawi AT, Gaylor DW, Hamernik K, Hodgson E, Karczmar AG, Padilla S, Pope CN, Richardson RJ, Saunders DR, Sheets LP, Sultatos LG and Wallace KB, 1998. Common mechanism of toxicity: a case study of organoposphorus pesticides. Toxicological Sciences 41(1), 8–20.
46. Miller MD, Crofton KM, Rice DC and Zoeller RT, 2009. Thyroid-disrupting chemicals: interpreting upstream biomarkers of adverse outcomes. Environmental Health Perspective, 117, 1033–1041.
47. Morreale de Escobar G, Obregón MJ and Escobar del Rey F, 2000. Is neurological development related to maternal hypothyroidism or to maternal hypothyroxinemia? Journal of Clinical Endocrinology and Metabolism, 85, 3975–3987.
48. Morillo-Bernal J, Fernández-Santos JM, Utrilla JC, de Miguel M, García-Marín R and Martín-Lacave I, 2009. Functional expression of the thyrotropin receptor in C cells: new insights into their involvement in the hypothalamic-pituitary-thyroid axis. Journal of Anatomy, 215(2), 150–8.
49. Moser VC, 2011. Functional assays for neurotoxicity testing. Toxicologic Pathology, 39, 36–45.
50. Nielsen E, Ostergaard G and Larsen JC, 2008. Toxicological Risk Assessments of Chemicals: A Practical Guide, Informa Healthcare, New York, pp. 140–143.
51. OECD (Organisation for Economic Co-operation and Development), 2007. Test Guideline 426. OECD Guideline for testing of chemicals, Developmental neurotoxicity study, 25 pp.
52. OECD (Organisation for Economic Co-operation and Development), 2010. Guidance for the derivation of an acute reference dose, 45 pp.
53. OECD (Organisation for Economic Co-operation and Development), 2012. Test Guideline 443. Guideline for the testing of chemicals Extended one-generation reproductive toxicity study, 25 pp.
54. Pan-Montojo F, Schwarz M, Winkler C, Arnhold M, O'Sullivan GA, Pal A, Said J, Marsico G, Verbavatz JM, Rodrigo-Angulo M, Gille G, Funk RH and Reichmann H, 2012. Environmental toxins trigger PD-like progression via increased alpha-synuclein release from enteric neurons in mice. Scientific Reports, 2(898), 1–12.
55. Parrón T, Requena M, Hernández AF and Alarcón R, 2011. Association between environmental exposure to pesticides and neurodegenerative diseases. Toxicology and Applied Pharmacology, 256, 379–585.
56. Picard D, 2003. SCOPE/IUPAC Project on Environmental Implications of endocrine active substances: molecular mechanisms of cross-talk between growth factors and nuclear receptor signalling. Pure and Applied Chemistry 75, 1743–1756.
57. SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), 2009. Assessment of the Antibiotic Resistance Effects of Biocides, 87 pp.
58. US EPA (United States Environmental Protection Agency), 2000. Science Policy on the use of data on cholinesterase inhibition for risk assessments of organophosphate and carbamate pesticides, 51 pp.
59. Singh AK, Tiwari MN, Upadhyay G, Patel DK, Singh D, Prakash O and Singh MP, 2012. Long term exposure to cypermethrin induces nigrostriatal dopaminergic neurodegeneration in adult rats: postnatal exposure enhances the susceptibility during adulthood. Neurobiology Aging, 33, 404–415.
60. Sook Han M, Shin KJ, Kim YH, Kim SH, Lee T, Kim E, Ho Ryu S and Suh PG, 2003. Thiram and ziram stimulate non-selective cation channel and induce apoptosis in PC12 cells. Neurotoxicology 24, 425–434.
61. Steinmaus C, Miller MD and Howd R, 2007. Impact of smoking and thiocyanate on perchlorate and thyroid hormone associations in the 2001–2002 national health and nutrition examination survey. Environmental Health Perspectives, 115, 1333–1338.
62. Tajima K, Miyagawa J, Nakajima H, Shimizu M, Katayama S, Mashita K and Tarui S, 1985. Morphological and biochemical studies on minocycline-induced black thyroid in rats. Toxicology and Applied Pharmacology, 81, 393–400.
63. Tilson HA, 1993. Neurobehavioral methods used in neurotoxicological research. Toxicology Letters 68 (1–2): 231–40.
64. US EPA (United States Environmental Protection Agency), 1986. Guidelines for the health risk assessment of chemical mixtures. Federal Register 51(185), 34014–34025.
65. US EPA (United States Environmental Protection Agency), 1989. Risk assessment Guidance for superfund, volume I: human health evaluation manual. Office of Emergency and Remedial Response. EPA/540/1-89/002.
66. US EPA (United States Environmental Protection Agency), 1998. Guidelines for Neurotoxicity Risk Assessment. Federal Register, Vol. 63, no. 93, 14th May 1998, Washington, DC.
67. US EPA (United States Environmental Protection Agency), 2006a. Organophosphate cumulative risk Assessment. Federal Register, 71(148), 43740–43742.
68. US EPA (United States Environmental Protection Agency), 2006b. Triazine cumulative risk assessment. Federal Register 71(119), 1–65.
69. US EPA (United States Environmental Protection Agency), 2006c. Chloroacetanilide cumulative risk assessment. Federal Register, 71(60), 1–74.
70. US EPA (United States Environmental Protection Agency), 2007. Revised N-methyl carbamate cumulative risk assessment. Federal Register, 72(186), 54656–54658.
71. US EPA (United States Environmental Protection Agency), 2011. Pyrethrins/Pyrethroid Cumulative Risk Assessment. 88 pp. Available on-line: www.regulations.gov/#!documentDetail;D=DPA-HQ-OPP-2011-0746-0003
72. US EPA (United States Environmental Protection Agency), 2013. Registration decision for the new active ingredient tolclofos-methyl, for use as as seed treatment on a variety of vegetable crops and ornamental plants, 14 pp.
73. US NRC (United States National Research Council), 2008. Phthalates Cumulative Risk Assessment – The Tasks Ahead. Committee on Phthalates Health Risks, National Research Council, National Academy of Sciences, Board on Environmental Science and Technology, National Academy Press, Washington, DC, 208 pp.
74. van der Mark M, Brouwer M, Kromhout H, Nijssen P, Huss A and Vermeulen R, 2012. Is pesticide use related to Parkinson disease? Some clues to heterogeneity in study results. Environmental and Health Perspectives, 120, 340–347.
75. Woodruff TJ, Zeise L, Axelrod DA, Guyton KZ Janssen S, Miller M, Miller GG, Schwartz JM, Alexeeff G, Anderson H, Birnbaum L, Bois F, Cogliano VJ, Crofton K, Euling SY, Foster PM, Germolec DR, Gray E, Hattis DB, Kyle AD, Luebke RW, Luster MI, Portier C, Rice DC, Solomon G, Vandenberg J and Zoeller RT, 2008. Meeting report: Moving upstream – Evaluating adverse upstream end points for improved risk assessment and decision-making. Environmental and Health Perspectives, 116, 1568–1575.
76. Yano BL, Bond DM, Novilla MN, McFadden LG and Reasor MJ, 2002. Spinosad insecticide: subchronic and chronic toxicity and lack of carcinogenicity in Fischer 344 rats. Toxicological Sciences, 65, 288–298.
77. Zabel M, 1976. The response of thyroid C-cell system in rat to long-term hypercalcemia. Endokrinologie 67(3), 315–321.