Regulatory considerations in developmental neurotoxicity of organophosphorus and carbamate pesticides*

Toxicology of Organophosphate & Carbamate Compounds

Volumn , Issue , 2006, Pages 633-641

  Makris, Susan L ^a  

^a U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33846017875     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-012088523-7/50044-2     Document Type: Chapter

References (63)

1. Adams J., Voorhees C.V., Middaugh L.D. Developmental neurotoxicity of anticonvulsants: Humans and animal evidence on phenytoin. Neurotoxicol. Teratol. 1990, 12(3):203-214.
2. Buelke-Sam J., Mactutus C.F. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity. Work Group II report: Testing methods in developmental neurotoxicity for use in human risk assessment. Neurotoxicol. Teratol. 1990, 12:269-274.
3. Buelke-Sam J., Kimmel C.A., Adams J., Nelson C.J., Vorhees C.V., Wright D.C., St. Omer V., Korol B.A., Butcher R.E., Geyer M.A., Holson J.F., Kutscher C.L., Wayner M.J. Collaborative behavioral teratology study: Results. Neurobehav. Toxicol. Teratol. 1985, 7:591-624.
4. Burbacher T.M., Rodier P.M., Weiss B. Methylmercury developmental neurotoxicity: A comparison of effects in humans and animals. Neurotoxicol. Teratol. 1990, 12(3):191-202.
5. Cook L.L., Jacobs K.S., Reiter L.W. Tin distribution in adult and neonatal rat brain following exposure to triethyltin. Toxicol. Appl. Pharmacol. 1984, 72(1):75-81.
6. Crofton K.M., Sutton J.L., Makris S.L., Raffaele K., Sette W.F. Developmental neurotoxicity testing guidelines: Variability in morphometric assessments of neuropathology, poster presentation No. 539, 40th annual meeting of the Society of Toxicology. Toxicologist 2001, 60:113. (1).
7. Crofton K.M., Makris S.L., Sette W.F., Mendez E., Raffaele K.C. A qualitative retrospective analysis of positive control data in developmental neurotoxicity studies. Neurobehav. Toxicol. Teratol. 2004, 26:345-352.
8. Davis J.M., Otto D.A., Weil D.E., Grant L.D. The comparative developmental neurotoxicity of lead in humans and animals. Neurotoxicol. Teratol. 1990, 12(3):215-230.
9. Driscoll C.D., Streissguth A.P., Riley E.P. Prenatal alcohol exposure: Comparability of effects in humans and animal models. Neurotoxicol. Teratol. 1990, 12(3):231-238.
10. Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel SAP Report No. 99-01B, January 22, 1999-Report: FIFRA Scientific Advisory Panel meeting, December 8, 1998, held at the Sheraton Crystal City Hotel, Arlington, VA. Session II-A set of scientific issues being considered by the Environmental Protection Agency regarding: A retrospective analysis of developmental neurotoxicity studies 1999, U.S. Environmental Protection Agency, Washington, DC.
11. Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel SAP Report No. 99-03A, May 25, 1999-Report: FIFRA Scientific Advisory Panel meeting, May 25, 1999, held at the Sheraton Crystal City Hotel, Arlington, VA. Session I-A set of scientific issues being considered by the Environmental Protection Agency regarding: Office of Pesticide Programs policy for the use of the FQPA 10X safety factor 1999, U.S. Environmental Protection Agency, Washington, DC.
12. Francis E.Z., Kimmel C.A., Rees D.C. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity: Summary and implications. Neurotoxicol. Teratol. 1990, 12:285-292.
13. Gavin C.E., Kates B., Gerkin L.A., Rodier P.A. Patterns of growth deficiency in rats exposed in utero to undernutrition, ethanol, or the neuroteratogen methylazoxymethanol (MAM). Teratology 1994, 49(2):113-121.
14. Ginsburg G., Hattis D., Sonawane B., Russ A., Banati P., Kozlak M., Smolenski S., Goble R. Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol. Sci. 2002, 66(2):185-200.
15. Goodlett C.R., Mahoney J.C., West J.R. Brain growth deficits following a single day of alcohol exposure in the neonatal rat. Alcohol 1989, 6(2):121-126.
16. Hunter D.L., Marshall R.S., Padilla S. Automated instrument analysis of cholinesterase activity in tissues from carbamate-treated animals: A cautionary note. Toxicol. Methods 1997, 7:143-153.
17. Hutchings D.E. Issues of risk assessment: Lessons from the use and abuse of drugs during pregnancy. Neurotoxicol. Teratol. 1990, 12(3):183-190.
18. Kimmel C.A., Makris S.L. Recent developments in regulatory requirements for developmental toxicology. Toxicol. Lett. 2001, 120:73-82.
19. Qualitative and quantitative comparability of human and animal developmental neurotoxicity. Neurotoxicol. Teratol. 1990, 12(3):173-292. C.A. Kimmel, D.C. Rees, E.Z. Francis (Eds.).
20. Levine T.E., Butcher R.E. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity, Work Group IV report: Triggers for developmental neurotoxicity testing. Neurotoxicol. Teratol. 1990, 12:281-284.
21. MacPhail R.C., Tilson H.A., Moser V.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., Winneke G. The IPCS collaborative study on neurobehavioral screening methods: I. Background and genesis. NeuroToxicology 1997, 18(4):925-928.
22. Makris S.L. A retrospective analysis of developmental neurotoxicity studies submitted to the U.S. EPA, presentation abstract No. 630, 43rd annual meeting of the Society of Toxicology. Toxicologist 2004, 78:130.
23. Makris S., Raffaele K., Sette W., Seed J. A Retrospective Analysis of Twelve Developmental Neurotoxicity Studies Submitted to the U.S. EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 1998, U. S. Environmental Protection Agency, Washington, DC.
24. Makris S.L., Raffaele K.C., Mendez E. A retrospective review of studies utilizing gavage dosing of pre-weaning rats demonstrates no adverse consequences of dosing procedures, poster presentation No. 380, 44th annual meeting of the Society of Toxicology. Toxicologist 2005, 84:77.
25. Mileson B.E., Brimijoin S., Chambers J.E., Dass P.D., Padilla S., Sheets L.P., Tayler P.W., Van Pelt C., Wallace K.B. Guidance for the design and interpretation of studies intended to characterize acetylcholinesterase activity in the peripheral nervous system 1999, Unpublished report of the International Life Sciences Institute, Risk Sciences Institute, Washington, DC.
26. Moser V.C., Tilson H.A., MacPhail R.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., Winneke G. The IPCS collaborative study on neurobehavioral screening methods: II. Protocol design and testing procedures. Neuro Toxicology 1997, 18(4):929-938.
27. National Academy of Sciences, National Research Council Risk Assessment in the Federal Government: Managing the Process 1983, National Academy Press, Washington, DC.
28. National Academy of Sciences, National Research Council Pesticides in the Diets of Infants and Children 1993, National Academy Press, Washington, DC.
29. National Academy of Sciences, Committee on Developmental Toxicology Scientific Frontiers in Developmental Toxicology and Risk Assessment 2000, National Academy Press, Washington, DC.
30. Pope C.N., Chakrabourti T.K., Chapman M.L., Farrar J.D., Arthun D. Comparison of in vivo cholinesterase inhibition in neonatal and adult rats by three organophosphorous pesticides. Environ. Toxicol. Pharmacol. 1991, 4:309-314.
31. Raffaele K., Gilbert M., Crofton K., Makris S., Sette W. Learning and memory tests in developmental neurotoxicity testing: A cross-laboratory comparison of control data, poster presentation No. 1342, 43rd annual meeting of the Society of Toxicology. Toxicologist 2004, 78:276.
32. Raffaele K.C., Sette W.F., Makris S.L., Moser V.C., Crofton K.M. Motor activity in developmental neurotoxicity testing: A cross-laboratory comparison of control data, poster presentation No. 598, 42nd annual meeting of the Society of Toxicology. Toxicologist 2003, 72:123.
33. Raffaele K.C., Sette W., Doherty J.D., Makris S., Crofton K.M. Neuropathological findings in developmental neurotoxicity testing: Comparison of qualitative and quantitative evaluations, poster presentation No. 977, 44th annual meeting of the Society of Toxicology. Toxicologist 2005, 84:200.
34. Reiter L.W., Heavner G.B., Dean K.F., Ruppert P.H. Developmental and behavioral effects of early postnatal exposure to triethyltin in rats. Neurobehav. Toxicol. Teratol. 1981, 3(3):285-293.
35. Rodier P.M., Koeter H.B. General activity from weaning to maturity in mice exposed to halothane or nitrous oxide. Neurobehav. Toxicol. Teratol. 1986, 8(2):195-199.
36. Rodier P.M., Reynolds S.S., Roberts W.N. Behavioral consequences of interference with CNS development in the early fetal period. Teratology 1979, 19(3):327-336.
37. Rodier P.M., Kates B., White W.A., White A.L. The relationship of rat brain weight and pituitary weight to postnatal growth after prenatal exposure to methylazoxymethanol. Neurotoxicol. Teratol. 1991, 13(6):583-590.
38. Rodier P.M., Ingram J.L., Tinsdale B., Nelson S., Romano J. Embryological origin for autism: Developmental anomalies of the cranial nerve motor nuclei. J. Comp. Neurol. 1996, 370(2):247-261.
39. Sager P.R., Aschner M., Rodier P.M. Persistent, differential alterations in developing cerebellar cortex of male and female mice after methylmercury exposure. Brain Res. 1984, 314(1):1-11.
40. Schull W.L., Norton S., Jensh R.P. Ionizing radiation and the developing brain. Neurotoxicol. Teratol. 1990, 12(3):249-260.
41. Sette W., Crofton K., Makris S., Doherty J., Raffaele K. Auditory startle reflex habituation in developmental neurotoxicity testing: A cross-laboratory comparison of control data, poster presentation No. 1341, 43rd annual meeting of the Society of Toxicology. Toxicologist 2004, 78:275.
42. Stanton M.E., Spear L.P. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity, Work Group I report: Comparability of measures of developmental neurotoxicity in humans and laboratory animals. Neurotoxicol. Teratol. 1990, 12:261-268.
43. Stine K.E., Reiter L.W., Lemasters J.J. Alkyltin inhibition of ATPase activites in tissue homogenates and subcellular fractions from adult and neonatal rats. Toxicol. Appl. Pharmacol. 1988, 94(3):3394-3406.
44. Tilson H.A., Jacobson J.L., Rogan W.J. Polychlorinated biphenyls and the developing nervous system: Cross-species comparisons. Neurotoxicol. Teratol. 1990, 12(3):239-248.
45. Tilson H.A., MacPhail R.C., Moser V.C., Becking G.C., Cuomo V., Frantik E., Kulig B.M., Winneke G. The IPCS collaborative study on neurobehavioral screening methods: VII. Summary and conclusions. NeuroToxicology 1997, 18(4):1065-1070.
46. Trasande L., Landrigan P.J. Editorial. The National Children's Study: A critical national investment. Environ. Health Perspect. 2004, 112(14):A789-A790.
47. Tyl R.W., Sette W. Workshop on the qualitative and quantitative comparability of human and animal developmental neurotoxicity, Work Group III report: Weight of evidence and quantitative evaluation of developmental neurotoxicity data. Neurotoxicol. Teratol. 1990, 12:275-280.
48. U.S. Environmental Protection Agency Developmental neurotoxicity study, series 83-6, Addendum 10 (neurotoxicity), subdivision F: Hazard evaluation: Human and domestic animals. EPA Publication No. 540/09-91-123; NTIS Publication No. PB 91-154617 1991, U.S. Environmental Protection Agency, Washington, DC.
49. U.S. Environmental Protection Agency Guidelines for developmental toxicity risk assessment. Fed. Reg. 1991, 56:63798-63826.
50. U.S. Environmental Protection Agency Proceedings of the U.S. EPA Workshop on Cholinesterase Methodologies 1992, U.S. Environmental Protection Agency, Washington, DC.
51. U.S. Environmental Protection Agency Reproductive toxicity risk assessment guidelines. Fed. Reg. 1996, 61:56274-56322.
52. U.S. Environmental Protection Agency Health effects test guidelines. OPPTS 870.6300, Developmental Neurotoxicity Study, EPA 712-C-98-239 1998, U.S. Environmental Protection Agency, Washington, DC.
53. U.S. Environmental Protection Agency Health effects test guidelines. OPPTS 870.3700, Prenatal Developmental Toxicity Study, EPA 712-C-98-207 1998, U.S. Environmental Protection Agency, Washington, DC.
54. U.S. Environmental Protection Agency Health effects test guidelines. OPPTS 870.6200, Neurotoxicity Screening Battery, EPA 712-C-98-238 1998, U.S. Environmental Protection Agency, Washington, DC.
55. U.S. Environmental Protection Agency Health effects test guidelines. OPPTS 870.3800, Reproduction and Fertility Effects, EPA 712-C-98-208 1998, U.S. Environmental Protection Agency, Washington, DC.
56. U.S. Environmental Protection Agency Guidelines for neurotoxicity risk assessment. Fed. Reg. 1998, 63:26926-26954.
57. U.S. Environmental Protection Agency Determination of the appropriate FQPA safety factor(s) for use in the tolerance-setting process 1998, Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency, Washington, DC.
58. U.S. Environmental Protection Agency Determination of the appropriate FQPA safety factor(s) in the organophosphorus pesticide cumulative risk assessment-Evaluation of sensitivity and susceptibility to the common mechanism of toxicity, acetylcholinesterase inhibition 1998, Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency, Washington, DC.
59. U.S. Environmental Protection Agency A review of the reference dose and reference concentration processes, risk assessment forum. EPA/630/P-02/002F 2002, U.S. Environmental Protection Agency, Washington, DC.
60. U.S. Environmental Protection Agency The N-methyl carbamate cumulative risk assessment: Pilot analysis, Background document for FIFRA Scientific Advisory Panel, February 15-18 2005, U.S. Environmental Protection Agency, Washington, DC.
61. Voorhees C.V., Klein K.L., Scott W.J. Aspirin-induced psychoteratogenesis in rats as a function of embryonic age. Teratogen. Carcinogen. Mutagen 1982, 2(1):77-84.
62. Weiss B., Amler S., Amler R.W. The vulnerability, sensitivity, and resiliency of the developing embryo, infant, child, and adolescent to the effects of environmental chemicals, drugs, and physical agents as compared to the adult pesticides. Pediatrics 2004, 113(4):1030-1036. Pt 2.
63. Wilson B.W., Padilla S., Henderson J.D., Brimijoin S., Dass P.D., Elliot G., Jaeger B., Lanz D., Pearson R., Spies R. Factors in standardizing automated cholinesterase assays. J. Toxicol. Environ. Health 1996, 48:187-195.